Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06281756 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

StatusRecruiting
PhaseEarly Phase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria shortened, about 11 wordsv7
  2. Primary completion date: Feb 2027 to Nov 30, 2027
    • Study completion date: Feb 2028 to May 31, 2028
    • Start date: Mar 14, 2024 to Mar 20, 2024
    v6
  3. Eligibility criteria expanded, about 23 wordsv5
  4. Site details revised at 1 of 4 sitesv4
  5. Site details revised at 2 of 4 sitesv3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 2024 to Mar 14, 2024
    • Site details revised at 4 of 4 sites
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06281756
Lead Sponsor Milton S. Hershey Medical Center
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Insomnia, Insomnia Chronic, Insomnia, Primary, Blood Pressure, Blood Pressure, High
Related terms Hypertension, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov