Insomnia study: Trazodone
Official title Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
ClinicalTrials.gov ID: NCT06281756
What this study is testing
What is Trazodone?
An investigational low‑dose medication being studied as a potential treatment for insomnia.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if people with short sleep insomnia or normal sleep insomnia respond differently to CBT‑I or trazodone, and how this affects blood pressure.
- Who it's for
- Adults who have chronic insomnia and high blood pressure.
- What's involved
- Participants will receive either CBT‑I or low‑dose trazodone, attend scheduled visits, and have their sleep and blood pressure monitored.
- Time commitment
- The study lasts several weeks, with multiple clinic visits for therapy, medication, and blood pressure checks.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Meets criteria for chronic insomnia
- Body Mass Index (BMI) 18.5 kg/m2 and higher
You likely can't join if
- 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...
- 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...
- Started new or changed treatment for sleep apnea in the past three months
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Denver, Colorado, United States
- Hershey, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Denver, Colorado, United States; Hershey, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States; Québec, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.