Trials / Recruiting
RecruitingNCT06281756
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
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Milton S. Hershey Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Cognitive Behavioral Treatment for Insomnia (CBT-I) | Subjects will receive therapy for 8 weeks |
| DRUG | Trazodone | Non-remitting subjects will receive Trazodone (dosage) for 8 weeks |
| OTHER | Placebo | Non-remitting subjects will receive placebo for 8 weeks |
Timeline
- Start date
- 2024-03-20
- Primary completion
- 2027-11-30
- Completion
- 2028-05-31
- First posted
- 2024-02-28
- Last updated
- 2025-11-10
Locations
4 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06281756. Inclusion in this directory is not an endorsement.