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Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

NCT02922894 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-11-25

No results posted yet for this study

Summary

This study will investigate potential therapeutic approaches for sleep-disordered breathing (SDB) in patients with chronic cervical spine injury (\>6 months post-injury).

Conditions

Interventions

PROCEDURE

Acute episodic hypoxia

The subjects will undergo 30 minutes of baseline monitoring followed by 15 episodes of one minute of episodic hypoxia with supplemental CO2 to maintain isocapnia. This is followed by a 45 minute recovery period.

PROCEDURE

Supplemental oxygen

Supplemental oxygen therapy for 6 weeks

DRUG

Trazodone

100mg before bedtime

DRUG

Placebo

One placebo pill before-bedtime

PROCEDURE

Sham

Room air will be administered instead of episodic hypoxia or supplemental oxygen..

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • John D. Dingell VA Medical Center

    lead FED

Principal Investigators

  • M Safwan Badr, M.D. · John D. Dingell VA Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2026-01-31
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Drugs
Diseases

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 NCT02922894 on ClinicalTrials.gov