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RecruitingEarly 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares two treatments for adults with long-term insomnia, or trouble sleeping: sleep-focused talk therapy (CBT-I) and low-dose trazodone medicine. It looks at sleep and blood pressure, and whether treatment works differently for people who sleep less versus those who sleep a normal amount.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Have long-term insomnia.
  • Can read and communicate well in English at U.S. sites, or English or French at the Canadian site.
  • Have a body mass index (BMI), a measure based on height and weight, of 18.5 or higher.

Who can't join

  • Unwilling to share an email address or cell phone number for survey links, or to stop insomnia treatments outside the study.
  • Ever diagnosed with psychosis or bipolar disorder; alcohol or drug abuse or dependence in the past year.
  • Sleep apnea (breathing pauses during sleep), repeated leg movements during sleep, excessive sleepiness disorders, or a sleep timing disorder, including night shift work. Other rules cover untreated apnea and apnea treatment changes in the past 3 months.
  • An unstable health condition; a fall causing a hospital stay, major injury, or broken bone in the past year; or 2 hospital stays or emergency visits for long-term conditions in the past year.
  • Current cancer treatment with chemotherapy or radiation, or any past diagnosis or treatment of long-term kidney failure, poor liver function, or long-term heart failure.
  • Sleep medicine more than twice a week; steroid medicines that act throughout the body; opioid medicines; or medicines that must not be taken with trazodone.
  • Pregnant, breastfeeding, planning pregnancy, or unwilling to use birth control during the study.
  • Seated blood pressure above 180 for the top number or 110 for the bottom number, or a heart tracing showing a corrected QT interval of 500 milliseconds or more (a measure of the heart’s electrical timing).

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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: * Age \< 18 * 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

Study sites (3)

CO

PA