RECRUITING

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

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Conditions

InsomniaInsomnia ChronicInsomnia, PrimaryBlood PressureBlood Pressure, Highsleepsleep disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-03-14
Study Completion:2028-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06281756

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 18 or older
  2. * 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.
  3. * Meets criteria for chronic insomnia
  4. * 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
  5. * Body Mass Index (BMI) 18.5-\<40 kg/m2
  1. * Age \< 18
  2. * 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.
  3. * Unwilling to share email address/cell phone number to accept survey links.
  4. * Life time diagnosis of psychotic or bipolar disorder
  5. * Current use of Positive Airway Pressure (PAP) therapy
  6. * Does not meet criteria for chronic insomnia
  7. * Meets criteria for narcolepsy or hypersomnia disorder
  8. * Meets criteria for circadian rhythm disorder (including night shift work)
  9. * Unstable medical conditions that would make participation unsafe or unfeasible
  10. * Falls resulting in hospitalization, significant injury or fracture within past 12 months
  11. * 2 hospitalizations or emergency room visits within past 12 months for chronic conditions
  12. * Active chemotherapy or radiation therapy for cancer
  13. * Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
  14. * Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
  15. * BMI less than 18.5 or greater than 40
  16. * Substance abuse or dependence in the past 12 months
  17. * Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
  18. * Current use of systemic corticosteroids or opiate medications
  19. * Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
  20. * Current use of medications contraindicated with trazodone
  21. * Sleep apnea or periodic leg movement disorder as determined by sleep study
  22. * Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
  23. * EKG corrected QT interval greater than or equal to 500 ms

Contacts and Locations

Study Contact

Carrie Criley
CONTACT
717-531-4123
ccriley@pennstatehealth.psu.edu

Principal Investigator

Alexandros Vgontzas, MD
PRINCIPAL_INVESTIGATOR
Professor, Psychiatry

Study Locations (Sites)

National Jewish Health
Denver, Colorado, 80206-2761
United States
Penn State University
Hershey, Pennsylvania, 17033
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213-3203
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Alexandros Vgontzas, MD, PRINCIPAL_INVESTIGATOR, Professor, Psychiatry

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-14
Study Completion Date2028-02

Study Record Updates

Study Start Date2024-03-14
Study Completion Date2028-02

Terms related to this study

Keywords Provided by Researchers

  • sleep
  • sleep disorder
  • insomnia

Additional Relevant MeSH Terms

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