NCT06281756RecruitingEarly phase 1
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia Phenotypes Based on Objective Sleep Duration: A Sequential Cohort/Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- 20 Mar 2024
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Milton S. Hershey Medical Center
- Diseases
- High blood pressure
- NCT number
- NCT06281756
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 600
- From 20 Mar 2024 to the primary completion date, 30 Nov 2027
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
- Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
- Current use of systemic corticosteroids or opiate medications
- Current use of medications contraindicated with trazodone
Other illness
- Life time diagnosis of psychotic or bipolar disorder
- Meets criteria for narcolepsy or hypersomnia disorder
- Meets criteria for circadian rhythm disorder (including night shift work)
- Unstable medical conditions that would make participation unsafe or unfeasible
- 2 hospitalizations or emergency room visits within past 12 months for chronic conditions
- Active chemotherapy or radiation therapy for cancer
- Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
- Sleep apnea or periodic leg movement disorder as determined by sleep study
Lab values
- EKG corrected QT interval greater than or equal to 500 ms
Age
- Age \< 18
Other
- Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
- Unwilling to share email address/cell phone number to accept survey links.
- Started new or changed treatment for sleep apnea in the past three months
- Does not meet criteria for chronic insomnia
- Falls resulting in hospitalization, significant injury or fracture within past 12 months
- Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
- BMI less than 18.5
- Substance abuse or dependence in the past 12 months
- Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
- Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
Who the study is looking for
- Age 18 or older
- Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
- Meets criteria for chronic insomnia
- Body Mass Index (BMI) 18.5 kg/m2 and higher
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universite Laval Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Penn State University Coordinator of this site? Confirm its status | Hershey | United States | Recruiting |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.