Recruiting

Sleep Apnea

Sponsor:

John D. Dingell VA Medical Center

Code:

NCT02922894

Conditions

Sleep Apnea

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Acute episodic hypoxia

Supplemental oxygen

Trazodone

Placebo

Sham

Study Details

Brief 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

Sleep Apnea

Spinal Cord Injury

Study ID

NCT02922894

Start date

Jun 9, 2017

Status verified date

Jun, 2026

Completion date

Jan 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. healthy adults between the ages of 18 - 89
2. chronic spinal cord injury patients (T6 and above), > 3 months since injury and not on mechanical ventilation, and have not received mechanical ventilation via tracheostomy in the past.

Exclusion Criteria:

1. subjects ≤ 17 yrs old
2. Pregnant and lactating females
3. History of head trauma that resulted in neurological symptoms or loss of consciousness
4. advanced heart, lung, metabolic, liver or chronic kidney disease.
5. severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy
6. extreme obesity defined for this protocol as BMI ≥ 40 kg/m2 (to avoid the effect of morbid obesity on ventilation).

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

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

Interventions

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.

Supplemental oxygen

Supplemental oxygen therapy for 6 weeks

Trazodone

100mg before bedtime

Placebo

One placebo pill before-bedtime

Sham

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

Primary outcome measure

  • Change in Tidal Volume [ Time Frame: 1 Week ]
  • Change in CO2 reserve (Delta-PETCO2-AT) [ Time Frame: 1 Week ]
  • Change in Apnea Hypopnea Index (AHI) [ Time Frame: 1 week ]
  • Change in hypocapnic apneic threshold [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

M Safwan Badr, M.D.

313-576-3548m.badr@va.gov

Locations

John D. Dingell VA Medical Center

Recruiting

Detroit, Michigan, United States, 48201

Contacts

M. Safwan Badr, MD

313-576-3548

More Information

Sponsor

John D. Dingell VA Medical Center

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John D. Dingell VA Medical Center on 2026-07-01.