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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Cognitive Behavioral Treatment for Insomnia (CBT-I)
  Subjects will receive therapy for 8 weeks
• Препарат Trazodone
  Non-remitting subjects will receive Trazodone (dosage) for 8 weeks
• Другое Placebo
  Non-remitting subjects will receive placebo for 8 weeks

Первичные конечные точки

• Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) [Срок оценки: 9 weeks]
• Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) [Срок оценки: 9 weeks]
• Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment [Срок оценки: 35 weeks]

Вторичные конечные точки (11)

• Insomnia Severity Index (ISI) Score following CBT-I [Срок оценки: 9 weeks]
• Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) [Срок оценки: 9 weeks]
• Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) [Срок оценки: 9 weeks]
• Evening Cortisol levels following CBT-I [Срок оценки: 9 weeks]
• Insomnia Severity Index (ISI) Score following RCT [Срок оценки: 9 weeks]
• PSG Total Sleep Time (TST) following RCT [Срок оценки: 9 weeks]
• Actigraphy Total Sleep Time (TST) following RCT [Срок оценки: 9 weeks]
• Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP) [Срок оценки: 9 weeks]
• Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP) [Срок оценки: 9 weeks]
• Evening Cortisol levels following RCT [Срок оценки: 9 weeks]
• Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment [Срок оценки: 35 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• National Jewish Health — Denver
• Penn State University — Hershey
• University of Pittsburgh — Pittsburgh

Канада · 1 центр

• Université Laval — Québec

Идентификаторы

NCT: NCT06281756 · STUDY00022285 · 1UG3HL161342-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗