Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

Part of paid clinical trials in Detroit, Michigan.

Sponsor
John D. Dingell VA Medical Center
Study ID
NCT02922894
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Accepted

Interventions

  • Acute episodic hypoxia — PROCEDURE
    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.
  • Supplemental oxygen — PROCEDURE
    Supplemental oxygen therapy for 6 weeks
  • Trazodone — DRUG
    100mg before bedtime
  • Placebo — DRUG
    One placebo pill before-bedtime
  • Sham — PROCEDURE
    Room air will be administered instead of episodic hypoxia or supplemental oxygen..

Study Details

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

Key Dates

Start date
Jun 9, 2017
Status verified
Mar 2025
Primary completion
Jan 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER

Arms

  • Experimental: Acute episodic hypoxia
    To test development of ventilatory augmentation following episodic hypoxia, defined as increased Hypoxic Ventilatory Response (HVR) from early to late hypoxic exposure episodes.
  • Experimental: Supplemental oxygen
    To use supplemental oxygen to decrease peripheral chemoreceptor activity in patients with SCI and central SDB. In addition, perform a repeat evaluation after treatment with supplemental oxygen or sham O2 for 6 weeks to determine if correction of chronic intermittent hypoxia, which mitigates sensory LTF, results in decreased propensity to central apnea.
  • Experimental: Trazodone or placebo
    examine the effect of trazodone on breathing during sleep

Primary Outcome Measure

Change in Tidal Volume [ Time Frame: 1 Week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John D. Dingell VA Medical CenterDetroitMichigan48201
M. Safwan Badr, MD
313-576-3548

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John D. Dingell VA Medical Center· Detroit, MI

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