NCT06281756 · Milton S. Hershey Medical Center
Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Life time diagnosis of psychotic or bipolar disorder
- 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.
- Started new or changed treatment for sleep apnea in the past three months
- Does not meet criteria for chronic insomnia
- 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
- Falls resulting in hospitalization, significant injury or fracture within past 12 months
- 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
- 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 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 pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
- Current use of medications contraindicated with trazodone
- Sleep apnea or periodic leg movement disorder as determined by sleep study
- Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
- EKG corrected QT interval greater than or equal to 500 ms
Where
- Denver, Colorado
- Hershey, Pennsylvania
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations