Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
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 insom
| Condition(s) | Insomnia, Insomnia Chronic, Insomnia, Primary, Blood Pressure, Blood Pressure, High |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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, |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Milton S. Hershey Medical Center |
| Locations | Denver, Colorado, United States; Hershey, Pennsylvania, United States; Pittsburgh, Pennsylvania, United States; Québec, Quebec, Canada |
| Start date | 2024-03-20 |
| NCT ID | NCT06281756 |
| Official listing | https://clinicaltrials.gov/study/NCT06281756 |