Trazodone on OSA Endotypes

NCT06286189 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 2020P002760-t
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Effect of trazodone on arousal threshold (%eupnea)

  Arousal threshold will be calculated non invasively from the home sleep test flow signal

  1 night

Secondary Outcomes (1)

• Effect of trazodone on apnea hypopnea index (events/h)

  1 night

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo capsule 30 min before sleep

Drug: Placebo oral tablet

Trazodone

EXPERIMENTAL

Trazodone capsule 30 min before sleep

Drug: Trazodone Hydrochloride

Interventions

Placebo oral tablet DRUG

Placebo capsule taken 30 min before sleep

Placebo

Trazodone Hydrochloride DRUG

Trazodone 100 mg 30 min before sleep

Trazodone

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Central Study Contacts

Ludovico Messineo

CONTACT

(617) 732-4013; lmessineo@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)