RECRUITING

Trazodone on OSA Endotypes

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Conditions

Obstructive Sleep Apnea

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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

Obstructive sleep apnea (OSA) is common and has major health implications but treatment options are limited. Some OSA patients with low arousal threshold wake up prematurely during an obstructive event and do not have time for spontaneous upper airway (UA) dilator muscle recruitment. As a consequence they are exposed to apnea and hypopnea cycling. In this protocol the investigators will test the effect of trazodone administered before sleep on OSA traits and OSA severity during sleep.

Official Title

Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity

Quick Facts

Study Start:2024-01-01
Study Completion:2025-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06286189

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:21 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Moderate-to-severe OSA (AHI ≥ 15 events/hr)
  1. * All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
  2. * Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
  3. * Use of SNRIs/SSRIs.
  4. * Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
  5. * Sleep disordered breathing or respiratory disorders other than obstructive sleep apnea:
  6. * Other sleep disorders: periodic limb movements (periodic limb movement arousal index \> 10/hr), narcolepsy, or parasomnias.
  7. * Hypersensitivity to the study drug (angioedema or urticaria)
  8. * Contraindications to DAW2020
  9. * Use of medications that lengthen QTc interval
  10. * Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
  11. * Severe claustrophobia.

Contacts and Locations

Study Contact

Ludovico Messineo
CONTACT
(617) 732-4013
lmessineo@bwh.harvard.edu

Study Locations (Sites)

Brigham and Women's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Brigham and Women's Hospital

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 Date2024-01-01
Study Completion Date2025-06-01

Study Record Updates

Study Start Date2024-01-01
Study Completion Date2025-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea