How to Start a Telehealth Insomnia Practice in Georgia

You’re a psychiatrist or PMHNP who sees the opportunity: millions of Americans can’t sleep, most never get proper treatment, and telehealth has made it possible to reach them from anywhere. But between licensing red tape, technology decisions, marketing costs, and compliance requirements, launching a telepsychiatry practice for insomnia can feel overwhelming.

Here’s the reality: starting a telehealth insomnia practice is absolutely doable, but it requires navigating a maze of state-specific regulations, making smart economic choices, and building operational systems that actually work. This guide walks you through exactly what it takes — from multi-state licensing to patient acquisition economics to handling the inevitable no-shows that plague sleep medicine.

Whether you’re a psychiatrist looking to expand your practice or a PMHNP ready to launch your own telehealth clinic, here’s what you need to know.

Why Insomnia Treatment Is Different (And Why That Matters for Your Practice)

Before diving into logistics, understand what makes an insomnia-focused practice unique operationally:

Insomnia requires both medication management AND behavioral intervention. Unlike straightforward medication management for other psychiatric conditions, effective insomnia treatment typically involves Cognitive Behavioral Therapy for Insomnia (CBT-I) alongside medication. This means you’re either getting trained in CBT-I yourself (adding complexity to appointments) or coordinating with therapists (adding administrative overhead).

Patient compliance is harder. Insomnia management demands lifestyle changes — sleep hygiene, routine adjustments, limiting screens before bed. You’ll spend extra time on patient education and follow-up compared to conditions where medication alone drives results. Budget longer appointments and more frequent check-ins, especially early in treatment.

Scheduling doesn’t fit the 9-to-5 model. Many insomnia patients work irregular hours or are most alert in the evening. Offering afternoon and evening slots can dramatically improve show rates and patient satisfaction — but it also means your clinical hours might not match a traditional practice.

Comorbidity complicates things. Insomnia rarely exists in isolation. Patients often have underlying anxiety, depression, chronic pain, or other conditions contributing to sleep issues. You’ll coordinate with primary care and other specialists more than in a pure psychiatric practice, which takes time.

The operational twist: insomnia practices often need digital sleep tracking tools, flexible scheduling systems, and clear protocols for when to refer patients for sleep studies or other diagnostic work. Factor these into your setup from day one.

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Step 1: Navigate Multi-State Licensing (The Biggest Headache)

If you’re doing telehealth, you must be licensed in every state where your patients are located. There’s no ‘national telehealth license’ — telemedicine is legally practicing medicine at the patient’s location.

For Psychiatrists (MD/DO)

The Interstate Medical Licensure Compact (IMLC) is your friend — if your states participate. As of 2026, 37 states plus DC and Guam are compact members. Among priority states:

• Texas, Florida, Illinois, and Pennsylvania: All IMLC members. If you’re already licensed in one compact state, you can use the streamlined process to get licensed in the others, potentially cutting timeline from months to weeks.
• California and New York: Not in the compact. You’ll go through each state’s full application process, which is slower and more paperwork-intensive.

Timeline reality check:

• Texas averages 51 days from completed application to licensure
• California warns applicants to apply at least 6 months in advance due to high volume
• Most other states fall in the 2-4 month range

Costs: Initial license fees run $300-$800 per state, plus background checks. If you’re targeting 5-6 states, budget $2,000-$4,000 just for licensing.

DEA registration: You need a separate DEA registration address in each state for prescribing controlled substances (which includes most sleep medications). Cost is ~$888 for a 3-year registration per address. Also enroll in each state’s Prescription Drug Monitoring Program (PDMP) — every state mandates checking this before prescribing controlled sleep meds.

For PMHNPs

It’s more complicated. Unlike physicians, there’s currently no active APRN compact for multi-state practice. You need separate APRN licenses for each target state.

Scope-of-practice laws vary wildly by state:

• New York: NPs with >3,600 hours of experience can practice independently without a physician collaborator (law effective 2023)
• Illinois: Full practice authority after 4,000 clinical hours plus 250 CE hours under a collaborative agreement
• Texas, Florida, Pennsylvania: Still require physician collaboration/supervision for psychiatric NPs

What this means operationally: If you’re an NP in Texas or Pennsylvania, you’ll need to contract with a collaborating physician (adding cost and complexity) or join a group practice. In New York or Illinois, experienced NPs can open a solo telehealth insomnia practice outright.

Florida’s special option: Florida offers an Out-of-State Telehealth Provider Registration if you hold an unencumbered license elsewhere. This is faster than full licensure (~2 weeks vs 2-3 months) but has limitations on prescribing Schedule II controlled substances via telehealth. For insomnia treatment, this works fine since most sleep meds (like zolpidem/Ambien, Schedule IV) aren’t Schedule II.

Current Telehealth Prescribing Rules

Critical update as of early 2026: The DEA and HHS extended COVID-era telehealth flexibilities through December 31, 2026. This means you can prescribe controlled insomnia medications (like Ambien) via telehealth without an initial in-person visit — at least through 2026 while permanent rules are finalized.

Plan for potential changes in 2027. If the DEA reverts to requiring in-person exams for controlled substance prescriptions, you’ll need referral partnerships with in-person providers or adjust your treatment approach.

Step 2: Set Up Your Business Structure and Technology

Legal and Business Setup

Form a legal entity: LLC or Professional Corporation (depending on your state’s rules for medical practices). This protects personal assets and simplifies tax handling.

Costs: State filing fees range from $50-$500. Budget $300-$600 for a brief consultation with a healthcare attorney to ensure you’re compliant with telehealth informed consent laws and other state-specific requirements.

Malpractice insurance: Secure a policy that explicitly covers telemedicine across all your target states. Telepsychiatry is lower risk than surgery, but if you’re prescribing controlled substances, premiums reflect that.

Costs: $1,500-$3,000/year for part-time coverage; $3,000-$5,000/year for full-time, depending on limits and states (higher in litigious states like New York and Florida).

Technology Stack

You need three core systems: HIPAA-compliant video, scheduling with automated reminders, and documentation/e-prescribing.

Option 1: All-in-one platforms like SimplePractice, Luminello, or Headway provide video, EHR, scheduling, and billing in one package. Cost: ~$50-$150/month depending on features.

Option 2: Piece it together for lower cost initially:

• Video: Doxy.me Professional (~$35/month) or Zoom for Healthcare
• Scheduling: Acuity, Calendly with HIPAA compliance, or EHR built-in scheduler
• EHR/Documentation: CharmHealth (~$25/month) or similar
• E-prescribing: Often included in EHR or via separate service like DrFirst

Total lean setup cost: $60-$100/month for tech, plus business-class internet ($50-$100/month).

Don’t invest in custom platform development unless you’re planning a large-scale operation. Solo or small practices can run efficiently on off-the-shelf solutions for a fraction of the $30,000+ custom development costs.

Other essentials:

• Professional website with clear information about your insomnia services (crucial for SEO)
• Secure domain and HIPAA-compliant email (Google Workspace with BAA or similar)
• Good webcam, noise-canceling headset, and reliable backup internet

Step 3: Build Your Clinical Workflow

Intake Process

Pre-visit questionnaires save time. Have patients complete sleep history forms, sleep diaries, or validated instruments (like the Insomnia Severity Index) before the first appointment. This frontloads data collection and lets you dive into treatment planning immediately.

Initial evaluation structure: Budget 60 minutes for first insomnia consultations. You’ll need time to:

• Review comprehensive sleep history
• Assess comorbid conditions (anxiety, depression, pain)
• Discuss sleep hygiene and behavioral interventions
• Create initial treatment plan (medication, CBT-I, or both)
• Handle informed consent for telehealth and treatment

Follow-ups: 30-minute appointments typically work for medication adjustments and behavioral coaching. Some providers offer brief 15-minute check-ins for established patients doing well.

Between-Visit Support

Decide on your communication boundaries early. Will you offer secure messaging for urgent sleep issues? Phone check-ins? Or is all communication via scheduled appointments?

Many successful insomnia practices use asynchronous messaging (via EHR portal) with clear response-time expectations (e.g., ‘I’ll respond within 24 hours on business days’). This provides patients reassurance without constant interruptions to your schedule.

Coordinating External Services

Sleep studies: Build relationships with sleep labs in each state you serve so you can easily refer patients who need diagnostic work (sleep apnea screening, etc.). Know where to send a Texas patient versus a New York patient.

CBT-I therapists: If you’re not providing CBT-I yourself, maintain a referral list of therapists trained in CBT-I in your target states. Some providers partner with specific therapists for coordinated care.

Step 4: Master the Economics — Cash Pay vs. Insurance

This is where many providers make or break their practice financially.

The Insurance Reality

Private insurers pay behavioral health providers about 22% less than for equivalent physical health services. This gap is why over one-third of psychiatrists opt out of insurance entirely.

The case for insurance:

• Volume: Being in-network dramatically increases patient flow, especially in competitive markets
• Accessibility: Many patients with insomnia won’t pay cash — they need insurance coverage
• Referrals: Primary care doctors and insurance directories drive steady referrals

The operational cost:

• Credentialing takes 3-6 months per insurer
• You need robust billing infrastructure (EHR with claims management or outsourced billing)
• Prior authorizations, claim denials, and appeals eat time and money
• Payment comes 30-90 days after service
• Reimbursement rates may not reflect your actual time invested

Note: Illinois recently passed legislation requiring commercial insurers to pay mental health providers at least 141% of Medicare rates. If this trend spreads, insurance participation may become more economically viable in other states.

The Cash-Pay Model

What makes it attractive for insomnia practices:

• Simpler operations: Payment at time of service, no claims, no prior auths
• Higher rates: Set fees that reflect your expertise (e.g., $250 for initial consult vs. $120 insurance reimbursement)
• Treatment autonomy: No insurer-imposed session limits or formulary restrictions
• Privacy: Some patients value keeping treatment off insurance records

The downside:

• Smaller patient pool: Limited to those who can afford out-of-pocket costs
• Marketing burden: Without insurer referrals, you rely entirely on SEO, word-of-mouth, and paid advertising
• Economic sensitivity: In states with large underinsured populations (Texas, Florida), cash-only limits your reach

Hybrid approach: Many successful practices are in-network with 1-2 major insurers (for baseline patient flow) while also accepting cash-pay patients. This balances accessibility with autonomy and financial stability.

Step 5: Patient Acquisition — The Hidden Cost Everyone Underestimates

Here’s what providers get wrong about marketing costs: they see platforms advertising ‘affordable patient acquisition’ and don’t calculate the full economics.

The DIY Marketing Reality

If you handle marketing yourself (SEO, Google Ads, directory listings), understand the real costs:

SEO takes 6-12 months of consistent investment (content creation, technical optimization, link building) before generating meaningful patient flow. Most solo providers don’t have the expertise or patience for this.

Google Ads for mental health keywords cost $15-40+ per click. Most clicks don’t convert to booked patients. Realistic cost per booked patient through PPC: $200-400+, factoring in:

• Ad spend testing and optimization
• Staff time to handle and qualify leads
• No-show rates from cold leads
• Failed campaigns and learning curve

Directory listings (Psychology Today, Zocdoc) charge monthly fees AND you compete with hundreds of providers on the same page. Total monthly cost including subscription and per-booking fees adds up fast.

Bottom line: Acquiring a qualified psychiatric patient through DIY marketing typically costs $200-500+ when you factor in ALL costs — not the $30-50 figures some marketing articles claim.

Pay-Per-Appointment Platforms

How they work: You pay a fee when a new patient books with you. Zocdoc is the prime example, charging $40-110 per new patient booking (psychiatry tends toward higher end in metro markets).

Critical detail: The fee is charged whether the patient shows up or not. Zocdoc considers their job done once the appointment is booked — managing no-shows is on you.

Advantages:

• No upfront marketing spend or monthly subscription fees
• Pay only for actual patient interest
• Easy to scale up or down based on demand

Disadvantages:

• Costs can escalate quickly with high volume (50 new patients at $100 each = $5,000/month)
• You absorb all no-show risk
• Quality varies — platforms optimize for bookings, not necessarily good fit

Platform-Based Patient Flow (The Klarity Model)

What’s different: Some platforms use a pay-per-appointment model but add crucial value: pre-qualified patients matched to your specialty, built-in telehealth infrastructure, and both insurance and cash-pay patient flow.

The economic case: Instead of spending $3,000-5,000/month on marketing with uncertain results (agency fees, ad spend, failed campaigns, staff time), you pay only when a qualified patient actually sees you.

Key benefits:

• No wasted spend on clicks that don’t convert
• Patients are already matched to your insomnia expertise
• Built-in technology eliminates separate platform costs
• You control your schedule — only pay when you see patients
• Guaranteed ROI versus gambling on marketing channels

When this makes sense: For providers who want to focus on clinical work rather than marketing, or those scaling up without hiring marketing staff, platforms that handle patient acquisition remove the risk entirely.

Subscription Marketing

Fixed monthly fee for directory listing or marketing services. Cost-predictable but risky if volume is low.

Example: $400/month for enhanced Psychology Today profile. If you only get 1 patient/month from it, your acquisition cost is $400 per patient — far higher than per-booking models.

When it works: Established practices with solid reputation and steady volume. The subscription amplifies existing demand rather than creating it from scratch.

Step 6: Handle the No-Show Problem Proactively

Sleep medicine clinics see some of the highest no-show rates in healthcare: 21% overall, nearly 30% for new patients.

Why insomnia patients miss appointments:

• Exhaustion and forgetfulness from chronic sleep deprivation
• Irregular sleep schedules (falling asleep at 7am, missing 8am appointment)
• Younger patients and uninsured individuals have higher no-show rates
• Feeling better and losing motivation to continue treatment

Good news: Telehealth significantly reduces no-show rates by removing travel barriers and making it easier to attend.

Strategies to Minimize No-Shows

1. Multiple automated reminders — Email and text reminders leading up to appointment (most telehealth platforms do this automatically)

2. Deposit or prepayment requirement — Especially for cash-pay, require credit card on file and charge a no-show fee (or full visit fee) for missed appointments without notice

3. Flexible scheduling — Offer afternoon and evening slots when insomnia patients are more alert; avoid early mornings if possible

4. Easy rescheduling — Encourage patients to reschedule rather than disappear if they can’t make an appointment

5. First-appointment focus — New patients are highest risk; consider confirmation calls or extra reminders for initial consultations

Monitor your no-show rate. If it’s above 10-15%, tighten your systems. Track patterns by time of day, day of week, patient demographics — then adjust.

Financial impact: At ~$200 per missed appointment in lost opportunity and overhead, 5 no-shows/week costs ~$50,000 annually. Reducing that rate directly improves your bottom line.

Step 7: Launch Checklist and Startup Costs

Lean Startup (Under $5,000)

Licensing & Credentials: $1,000-$2,000

• State medical licenses and fees
• DEA registration
• PDMP enrollment

Legal Setup: $300-$500

• Business entity formation
• Brief attorney consultation

Insurance: $2,000-$3,000 (first year)

• Malpractice coverage for telehealth

Technology: $500 (first 3-4 months)

• Video platform, EHR, scheduling tools
• Website domain and hosting

Marketing: $500 initially

• Google My Business listing
• Initial directory listings or small ad budget

Total lean launch: ~$4,000-$6,000

Mid-Range Setup ($10,000-$15,000)

Add to lean startup:

• More aggressive marketing budget ($2,000-$3,000)
• Better technology stack or custom website
• Virtual assistant for scheduling/admin
• CBT-I training course

Premium Setup ($25,000+)

For those planning multi-state coverage from day one:

• Multiple state licenses and expedited processing
• Professional marketing firm for SEO and ads
• Comprehensive EHR with full revenue cycle management
• Staff support (billing specialist, VA)

Reality check: Most successful telehealth insomnia practices start lean, validate the model with real patients, then reinvest profits into scaling. Don’t overspend on tech or marketing before proving demand.

State-Specific Considerations

The Bottom Line: Is It Worth It?

Starting a telehealth insomnia practice requires:

• 3-6 months for licensing across target states
• $4,000-$15,000 in startup costs depending on scale
• Smart technology choices (don’t overbuild)
• Clear economic decision on insurance vs. cash-pay
• Proactive patient acquisition strategy that accounts for real costs

The opportunity is enormous: Millions suffer from insomnia, most never get evidence-based treatment, and telehealth removes traditional access barriers.

The economics can work: Whether you choose insurance panels for volume, cash-pay for autonomy, or a platform that handles patient acquisition while you focus on clinical care, there’s a viable path to a profitable practice.

The key differentiators for success:

1. Multi-state licensing strategy that balances reach with administrative burden
2. Honest accounting of patient acquisition costs and ROI by channel
3. Systems to minimize no-shows (automated reminders, deposits, flexible scheduling)
4. Clinical workflow that addresses both medication and behavioral components efficiently

The providers who succeed in telehealth insomnia treatment are those who treat practice-building as seriously as clinical care — understanding the regulations, optimizing the economics, and building systems that actually work.

Ready to reach patients who desperately need better sleep? The infrastructure is available, the demand is proven, and with smart operational decisions, you can build a practice that’s both clinically rewarding and financially sustainable.

Frequently Asked Questions

Do I need a separate license in every state where my patients are located?

Yes. Telemedicine is legally considered practicing medicine at the patient’s location, so you must be licensed in each state. The Interstate Medical Licensure Compact (IMLC) streamlines this for physicians in participating states (37 states as of 2026, including Texas, Florida, Illinois, and Pennsylvania — but not California or New York). NPs must obtain separate APRN licenses for each state with no current compact option.

Can I prescribe sleep medications via telehealth without seeing patients in person?

As of 2026, yes — through December 31, 2026. The DEA and HHS extended COVID-era flexibilities allowing telehealth prescribing of controlled substances (including common insomnia medications like zolpidem/Ambien) without an initial in-person visit. Plan for potential regulatory changes in 2027 when permanent rules are finalized.

How much does it really cost to acquire a new patient?

Much more than marketing platforms claim. DIY marketing (SEO, Google Ads, directories) typically costs $200-500+ per acquired patient when you factor in ad spend, staff time, no-shows from cold leads, and months of testing. Platforms using pay-per-appointment models charge $40-110 per booking but you pay even if the patient doesn’t show. The most cost-effective approach is often a platform that provides pre-qualified patients matched to your specialty, where you only pay when patients actually see you.

Should I accept insurance or go cash-pay for an insomnia practice?

It depends on your goals and market. Insurance brings volume and accessibility but adds administrative burden and typically pays 22% less than for physical health services. Cash-pay offers higher rates ($250+ vs ~$120 for insurance reimbursement), simpler operations, and treatment autonomy — but limits your patient pool to those who can pay out-of-pocket. Many successful practices use a hybrid approach: in-network with 1-2 major insurers for baseline flow while accepting cash patients for premium access.

How do I handle the high no-show rates common in sleep medicine?

Sleep clinics see ~21% overall no-show rates, nearly 30% for new patients. Strategies: implement automated reminders (email/text), require deposits or prepayment with credit card on file, offer flexible scheduling (afternoons/evenings when patients are more alert), make rescheduling easy, and focus extra attention on first appointments (confirmation calls, multiple reminders). Telehealth significantly reduces no-shows compared to in-person care by removing travel barriers.

What’s the minimum technology investment needed to start?

You can launch for $60-100/month using off-the-shelf solutions: HIPAA-compliant video platform like Doxy.me ($35/month), basic EHR with e-prescribing like CharmHealth ($25/month), and scheduling software (often included in EHR or via low-cost tools like Acuity). Add business-class internet and a professional website for patient education/SEO. Total lean tech stack: $500 for first few months. Avoid custom platform development ($30,000+) unless planning large-scale operations.

How long does it take to get licensed in different states?

Texas: ~51 days average once application complete. California: 4-6+ months (apply at least 6 months in advance). Most states: 2-4 months. IMLC expedites multi-state licensing for physicians in compact states, potentially reducing to weeks. Budget extra time for DEA registration in each state (~2-4 weeks) and PDMP enrollment.

Can PMHNPs practice independently via telehealth, or do they need physician supervision?

It varies by state. New York allows independent practice after 3,600 hours of experience; Illinois after 4,000 hours plus extra training. Texas, Florida, and Pennsylvania still require physician collaboration for psychiatric NPs. If you’re in a supervision-required state, you’ll need to contract with a collaborating physician (adding cost) or join a group practice. California is transitioning to independent practice but requires 3 years under supervision in approved settings first.

Citations and Sources

1. HHS Press Release – ‘DEA Telemedicine Flexibilities Extended Through 2026’ (January 2, 2026)
   www.hhs.gov/press-room/dea-telemedicine-extension-2026.html
   Official announcement extending COVID-era telehealth prescribing rules for controlled substances through December 31, 2026

2. Florida Statutes §456.47 – Telehealth and Controlled Substance Prescribing (Updated 2025)
   www.leg.state.fl.us/statutes/index.cfm?Appmode=DisplayStatute&URL=0400-0499/0456/Sections/0456.47.html
   Florida law prohibiting Schedule II controlled substance prescribing via telehealth except under specific exceptions

3. Interstate Medical Licensure Compact – Member State Information (2024)
   imlcc.com/information-for-states/
   Official compact commission data showing 37 participating states plus DC and Guam

4. Medical Board of California – Physician Licensure Application Processing Times (November 2025)
   mbc.ca.gov/Licensing/Physicians-and-Surgeons/Apply/processing-times.aspx
   Official timeline data showing 6+ month processing for physician licenses

5. Texas Medical Board – Licensing Application Processing Timeline
   www.tmb.state.tx.us/17-how-long-does-it-take-process-physician-licensure-application
   Legislatively mandated 51-day average processing time for physician licensure

6. Axios Chicago – ‘Illinois Bill Could Make Mental Health Care More Affordable’ (March 6, 2025)
   www.axios.com/local/chicago/2025/03/06/illinois-mental-health-bill-reimbursement-rates
   Report citing that private insurers pay behavioral health providers about 22% less than for physical health services

7. Journal of Clinical Sleep Medicine (via PMC) – No-Show Rates in Sleep Clinic Study (September 2020)
   pmc.ncbi.nlm.nih.gov/articles/PMC7970619/
   Peer-reviewed research showing 21.2% overall no-show rate and 30.5% for new patients in sleep medicine

8. BMC Health Services Research (via PMC) – Telehealth vs In-Person Attendance Meta-Analysis (September 2023)
   pmc.ncbi.nlm.nih.gov/articles/PMC12063363/
   Systematic review confirming telehealth significantly reduces non-attendance rates compared to in-person care

9. Zocdoc Provider Help Center – Understanding Zocdoc Pricing and Billing (Updated January 2026)
   www.zocdoc.com/provider-help/en/articles/10859404-understanding-zocdoc-pricing-and-billing
   Official documentation explaining pay-per-booking model and that fees are charged regardless of patient attendance

10. Pennsylvania Department of State – Interstate Medical Licensure Compact Information
    www.pa.gov/agencies/dos/department-and-offices/bpoa/boards-commissions/medicine/interstate-medical-licensure-compact.html
    Official state documentation of Pennsylvania’s IMLC participation and expedited multi-state licensing process

All sources accessed and verified as current as of February 10, 2026. Providers should continuously monitor state medical boards and federal agencies for regulatory updates beyond this date.

Source:

• https://www.leg.state.fl.us/statutes/index.cfm?Appmode=DisplayStatute&URL=0400-0499%2F0456%2FSections%2F0456.47.html#:~:text=provider%20may%20not%20use%20telehealth,in%20Schedule%20II%20of%20s
• https://www.hhs.gov/press-room/dea-telemedicine-extension-2026.html#:~:text=WASHINGTON%E2%80%94JANUARY%202%2C%202026%E2%80%94The%20U,while%20permanent%20rules%20are%20finalized
• https://www.pa.gov/agencies/dos/department-and-offices/bpoa/boards-commissions/medicine/interstate-medical-licensure-compact.html#:~:text=The%20Interstate%20Medical%20Licensure%20Compact,representatives%20from%20each%20member%20state
• https://imlcc.com/information-for-states/#:~:text=The%20Compact%20currently%20includes%2037,became%20operational%20in%20April%202017
• https://www.rivkinrounds.com/2022/04/new-law-allows-experienced-nps-to-practice-independently-in-ny/#:~:text=New%20York%E2%80%99s%202023%20state%20budget%2C,looked%20at%20on%20an%20individual
• https://www.nursingnetwork.com/newsletters/401#:~:text=,experience%20after%20obtaining%20national%20certification
• https://www.axios.com/local/chicago/2025/03/06/illinois-mental-health-bill-reimbursement-rates#:~:text=The%20big%20picture%3A%20Private%20insurance,the%20Medicare%20rate%20for%20mental
• https://www.axios.com/local/chicago/2025/03/06/illinois-mental-health-bill-reimbursement-rates#:~:text=new%20provider,in%20private%20practice%20tells%20Axios
• https://pmc.ncbi.nlm.nih.gov/articles/PMC7970619/#:~:text=Results%3A
• https://pmc.ncbi.nlm.nih.gov/articles/PMC7970619/#:~:text=A%20total%20of%202%2C532%20clinical,P%20%3C%20.0001%29%2C%20and