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Recruiting NCT06281756

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

Early Phase I Interventional Insomnia Insomnia Chronic Insomnia, Primary Blood Pressure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive Behavioral Treatment for Insomnia (CBT-I), Trazodone, Placebo.
Who it may be relevant to
Registry conditions: Insomnia, Insomnia Chronic, Insomnia, Primary, Blood Pressure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I) [Time frame: 9 weeks]
  • Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT) [Time frame: 9 weeks]
  • Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment [Time frame: 35 weeks]
Secondary outcome measures (11)
  • Insomnia Severity Index (ISI) Score following CBT-I [Time frame: 9 weeks]
  • Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) [Time frame: 9 weeks]
  • Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I) [Time frame: 9 weeks]
  • Evening Cortisol levels following CBT-I [Time frame: 9 weeks]
  • Insomnia Severity Index (ISI) Score following RCT [Time frame: 9 weeks]
  • PSG Total Sleep Time (TST) following RCT [Time frame: 9 weeks]
  • Actigraphy Total Sleep Time (TST) following RCT [Time frame: 9 weeks]
  • Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP) [Time frame: 9 weeks]
  • Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP) [Time frame: 9 weeks]
  • Evening Cortisol levels following RCT [Time frame: 9 weeks]
  • Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment [Time frame: 35 weeks]

Eligibility criteria

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, 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • National Jewish Health — Denver
  • Penn State University — Hershey
  • University of Pittsburgh — Pittsburgh
Canada · 1 center
  • Université Laval — Québec

Identifiers

NCT: NCT06281756 · STUDY00022285 · 1UG3HL161342-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗