Clinical trial NCT06281756: Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Insomnia
Insomnia Chronic
Insomnia, Primary
Blood Pressure
Blood Pressure, High
Keywords: sleep
sleep disorder
insomnia
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-02-28
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A 4-site (Hershey, Pennsylvania; Pittsburgh, Pennsylvania; Denver, Colorado; and Quebec, Canada) cohort study will examine the effect of CBT-I as a recommended first-line treatment for insomnia. This will be followed by a placebo-controlled randomized controlled trial (RCT) in those who do not remit in the Cohort Study. The subsequent RCT will compare the efficacy of trazodone vs. placebo among CBT-I non-remitters.
Primary purpose: TREATMENT

Brief 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.


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
* Current use of supplemental oxygen for the treatment of sleep apnea
* 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

Primary outcomes:
measure: Remission of insomnia symptoms following Cognitive Behavioral Therapy for Insomnia (CBT-I)
timeFrame: 9 weeks
measure: Remission of insomnia symptoms following trazodone/placebo Randomized Controlled Trial (RCT)
timeFrame: 9 weeks
measure: Remission of insomnia symptoms 6 months following completion of CBT-I Or RCT Treatment
timeFrame: 35 weeks
Secondary outcomes:
measure: Insomnia Severity Index (ISI) Score following CBT-I
timeFrame: 9 weeks
measure: Polysomnography (PSG) Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
timeFrame: 9 weeks
measure: Actigraphy Sleep efficiency following Cognitive Behavioral Therapy for Insomnia (CBT-I)
timeFrame: 9 weeks
measure: Evening Cortisol levels following CBT-I
timeFrame: 9 weeks
measure: Insomnia Severity Index (ISI) Score following RCT
timeFrame: 9 weeks
measure: PSG Total Sleep Time (TST) following RCT
timeFrame: 9 weeks
measure: Actigraphy Total Sleep Time (TST) following RCT
timeFrame: 9 weeks
measure: Home Blood Pressure (HBP) Morning Systolic Blood Pressure (SBP)
timeFrame: 9 weeks
measure: Home Blood Pressure (HBP) Morning Diastolic Blood Pressure (DBP)
timeFrame: 9 weeks
measure: Evening Cortisol levels following RCT
timeFrame: 9 weeks
measure: Evening Cortisol levels 6 months following completion of CBT-I or RCT Treatment
timeFrame: 35 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Hershey
country: United States
facility: Penn State University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Quebec
country: Canada
facility: Université Laval
Study officials:
affiliation: Professor, Psychiatry
name: Alexandros Vgontzas, MD
role: PRINCIPAL_INVESTIGATOR
References: