Trazodone on OSA Endotypes

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect of Trazodone on Obstructive Sleep Apnea Endotypes and Severity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06286189
• Other study ID #: 2020P002760-t
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: January 1, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: Ludovico Messineo
• Phone: (617) 732-4013
• Email: lmessineo[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Two overnight home sleep studies will be performed: a drug night and a placebo night. The patient will breath spontaneously (without CPAP) for both nights. On the study nights, subjects be instrumented with a full polygraphy for monitoring sleep, and respiratory events. Trazodone 100 mg will be given 30 min before lights out. At least four hours of sleep with high quality signal acquisition will be required for a study to be judged adequate. After the first overnight study is completed, there will be a one-week washout period prior to crossing over to the other treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: June 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Moderate-to-severe OSA (AHI = 15 events/hr)

Exclusion Criteria:

• All participants will be healthy and without major organ system disease that would preclude undergoing the physiological measurements.
• Use of medications expected to stimulate or depress respiration (including opioids, barbiturates, acetazolamide, doxapram, almitrine, theophylline, 4-hydroxybutanoic acid).
• Use of SNRIs/SSRIs.
• Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorder, heart failure (also below), or any other unstable major medical condition.
• Sleep disordered breathing or respiratory disorders other than obstructive sleep

apnea:

• Other sleep disorders: periodic limb movements (periodic limb movement arousal index > 10/hr), narcolepsy, or parasomnias.
• Hypersensitivity to the study drug (angioedema or urticaria)
• Contraindications to DAW2020
• Use of medications that lengthen QTc interval
• Hypokaliemia, hypomagnesemia, uncontrolled thyroid disease
• Severe claustrophobia.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Placebo oral tablet
Placebo capsule taken 30 min before sleep
• Trazodone Hydrochloride
Trazodone 100 mg 30 min before sleep

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of trazodone on arousal threshold (%eupnea)	Arousal threshold will be calculated non invasively from the home sleep test flow signal	1 night
Secondary	Effect of trazodone on apnea hypopnea index (events/h)	Apnea hypopnea index will be calculated from the home sleep test	1 night