Trazodone on OSA Endotypes

NCT ID: NCT06286189

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-06-01

Brief 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.

Detailed 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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo capsule 30 min before sleep

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Placebo capsule taken 30 min before sleep

Trazodone

Trazodone capsule 30 min before sleep

Group Type: EXPERIMENTAL

Trazodone Hydrochloride

Intervention Type: DRUG

Trazodone 100 mg 30 min before sleep

Interventions

Placebo oral tablet

Placebo capsule taken 30 min before sleep

Intervention Type: DRUG

Trazodone Hydrochloride

Trazodone 100 mg 30 min before sleep

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ludovico Messineo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ludovico Messineo

Role: CONTACT

lmessineo@bwh.harvard.edu

(617) 732-4013

Facility Contacts

Nicole Calianese, BS

Role: primary

ncalianese@mgb.org

617-732-8976

Other Identifiers

2020P002760-t

Identifier Type: -

Identifier Source: org_study_id