MedTrace Logo

Trazodone Dose Tolerance and APAP Adherence

NCT02945644 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-05-11

No results posted yet for this study

Summary

Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal dosing is unknown. This study looks at what dose of trazodone has the best balance of potential benefits to side-effects in people with obstructive sleep apnea who are either starting on positive airway pressure therapy or not adherent to it. Participants will be randomly assigned to one of three groups: trazodone 50 mg, trazodone 100 mg, or placebo for 14 days. The investigators will monitor side-effects and adherence to positive airway pressure therapy.

Conditions

  • Sleep Apnea, Obstructive

Interventions

DRUG

Trazodone

take at bedtime for 14 days

DRUG

Placebo

take at bedtime for 14 days

Sponsors & Collaborators

  • Louis Stokes VA Medical Center

    lead FED

Principal Investigators

  • Kingman P Strohl, MD · Louis Stokes Cleveland VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-13
Primary Completion
2020-09-30
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02945644 on ClinicalTrials.gov