Philadelphia, PANCT07542756Now EnrollingIRB Ready

Insomnia Clinical Trial in Philadelphia, PA

Access cutting-edge insomnia treatment through this clinical trial at a research site in Philadelphia. Study-provided care at no cost to qualified participants.

Sponsored by University of Pennsylvania

Quick Self-Assessment

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Expert Care in Philadelphia

Access insomnia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related insomnia treatment provided free

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Check if you qualify for this insomnia clinical trial in Philadelphia, PA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Philadelphia

    Convenient for PA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Philadelphia site if eligible
  4. 4Begin participation

About This Insomnia Study in Philadelphia

The purpose of this study is to assess the relative effectiveness, safety, and durability of the most commonly used prescription (zolpidem, trazodone) and over-the-counter (OTC) (melatonin, diphenhydramine) medications for insomnia, as well as a less commonly used prescription that may have a better risk/benefit profile (doxepin).

Sponsor: University of Pennsylvania

Who Can Participate

Inclusion Criteria

Adults aged 18-80 years.
Meet DSM-5 criteria for Insomnia Disorder.
Score ≥15 on the Insomnia Severity Index (ISI).
Sleep initiation and/or maintenance complaints: ≥30 minutes in duration, occurring ≥3 nights/week, with a duration of ≥3 months.
Willingness to discontinue use of all sleep-related medications prior to enrollment.
Completion of a 2-week washout period before starting any study medication.
Willingness to provide clinician assent for participation.

Exclusion Criteria

Patients will be ineligible if they meet any of the following criteria: self-reported daytime napping (≥1 hour per day on ≥3 days per week); a history of suicidal attempts or current ideation, acute or chronic psychiatric or medical condition not controlled by therapy (according to their primary care physician), or current alcohol or drug misuse; or the diagnoses of (or high risk for) other sleep disorders, including circadian rhythm disorders (phase advance or phase delay syndromes), shift work related sleep disorder ("day sleepers" who work \~11pm to 7am) and those with rotating shiftwork schedules. To determine eligibility, all subjects will be screened using a multitier process including: an online screener; an intake interview; a review of the subjects EMR; and, finally, the receipt of the patient's PCP's assent. The following provides additional listing and details (AD) for the Exclusion Criteria: General Considerations
Age \< 18 or \> 80 years old
Inadequate English language comprehension
Minimal facility with smartphones, computers, i-Pads, or the internet. Women's Health Given the potential for teratogenic effects with at least trazodone (FDA Class C), women intending to become pregnant, or who are pregnant, or who are breastfeeding will not be eligible for the study. Women will be asked to confirm the use of birth control using self-report and, if applicable, by providing evidence of contraceptive medication (e.g., prescription or pill pack). We will perform a urine pregnancy test at baseline for female participants who are of reproductive age to confirm eligibility. At study enrollment, participants will be told to alert the study team and stop taking study medications if they become pregnant. Participants will be asked to test for pregnancy in the event of a missed cycle. Medical and Psychiatric Considerations
Acute or unstable psychiatric conditions
Unstable medical condition, significant medical disorder, or acute illness (as determined by their PCP), within one month prior to the study period.
Significant liver or kidney problems
Pheochromocytoma or porphyria (contraindicated for trazodone)
Epilepsy or Seizure Disorder (contraindicated for trazodone)
Glaucoma or urinary retention (contraindicated for doxepin)
Increased ocular pressure (contraindicated for diphenhydramine)
Diagnosis of alcohol or substance use disorder within 2 years prior to the screening visit
Inability to refrain from drinking alcohol or substance use for at least 3 consecutive days Sleep Disorders and Sleep Habits
Any lifetime history of (diagnosis of) breathing disorders, including COPD and sleep apnea.
Shift work related sleep disorder (work \~11pm to 7am and "day sleeper") and rotating shiftwork schedules
Circadian rhythm disorders (phase advance or phase delay syndromes)
Self-reported usual daytime napping ≥1 hour per day (3 or more days per week) Medications and Concomitant meds
Known hypersensitivity or contraindication to study drugs
Known hypersensitivity or contraindication to drugs of the same class as the study treatments
Known hypersensitivity or contraindication to any excipients of the study drug formulation
Treatment with CNS active drugs prohibited by the protocol for five half-lives of the respective drug (or 2 weeks) Lifestyle
Heavy tobacco use (≥1 pack of cigarettes a day or inability to refrain from smoking during the night)
Not able or willing to stop treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Philadelphia?

Yes, this clinical trial (NCT07542756) has an active research site in Philadelphia, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Insomnia Treatment Options in Philadelphia, PA

If you're searching for insomnia treatment options in Philadelphia, PA, this clinical trial (NCT07542756) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Philadelphia research site is actively enrolling participants for this clinical trial. You'll receive care from experienced insomnia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all insomnia clinical trials near you to find additional studies recruiting in your area.

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