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

Description

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.

Conditions

Insomnia, Insomnia Chronic, Insomnia, Primary, Blood Pressure, Blood Pressure, High

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Study Overview

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Study Details

Study 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.

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

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

Condition
Insomnia
Intervention / Treatment

-

Contacts and Locations

Denver

National Jewish Health, Denver, Colorado, United States, 80206-2761

Hershey

Penn State University, Hershey, Pennsylvania, United States, 17033

Pittsburgh

University of Pittsburgh, Pittsburgh, Pennsylvania, United States, 15213-3203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * Takes anti-hypertensive medication (same regimen for at least 3 months); or elevated blood pressure, defined as seated SBP ≥120 mmHg or DBP ≥80 mmHg, measured in the research clinic
  • * Body Mass Index (BMI) 18.5-\<40 kg/m2
  • * 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 Positive Airway Pressure (PAP) therapy
  • * 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 or greater than 40
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Milton S. Hershey Medical Center,

Alexandros Vgontzas, MD, PRINCIPAL_INVESTIGATOR, Professor, Psychiatry

Study Record Dates

2028-02