NCT02922894

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
2mo left

Started Jun 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Jun 2017Jun 2026

First Submitted

Initial submission to the registry

September 23, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 4, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

June 9, 2017

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

November 25, 2025

Status Verified

March 1, 2025

Enrollment Period

8.7 years

First QC Date

September 23, 2016

Last Update Submit

November 20, 2025

Conditions

Sleep ApneaSpinal Cord Injury

Outcome Measures

Primary Outcomes (4)

  • Change in Tidal Volume

    Change in tidal volume from baseline to recovery period.

    1 Week

  • Change in CO2 reserve (Delta-PETCO2-AT)

    CO2 reserve is the requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative

    1 Week

  • Change in Apnea Hypopnea Index (AHI)

    AHI is used to indicate the severity of sleep apnea.

    1 week

  • Change in hypocapnic apneic threshold

    The nadir pressure in the upper airway (supra-glotic pressure) prior to the occurrence of an arousal. This is a physiological parameter.

    1 week

Study Arms (3)

Acute episodic hypoxia

EXPERIMENTAL

To test development of ventilatory augmentation following episodic hypoxia, defined as increased Hypoxic Ventilatory Response (HVR) from early to late hypoxic exposure episodes.

Procedure: Acute episodic hypoxiaProcedure: Sham

Supplemental oxygen

EXPERIMENTAL

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.

Procedure: Supplemental oxygenProcedure: Sham

Trazodone or placebo

EXPERIMENTAL

examine the effect of trazodone on breathing during sleep

Drug: TrazodoneDrug: Placebo

Interventions

Acute episodic hypoxiaPROCEDURE

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.

Acute episodic hypoxia
Supplemental oxygenPROCEDURE

Supplemental oxygen therapy for 6 weeks

Supplemental oxygen
TrazodoneDRUG

100mg before bedtime

Trazodone or placebo
PlaceboDRUG

One placebo pill before-bedtime

Trazodone or placebo
ShamPROCEDURE

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

Acute episodic hypoxiaSupplemental oxygen

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy adults between the ages of 18 - 89
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

John D. Dingell VA Medical Center

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea SyndromesSpinal Cord Injuries

Interventions

Trazodonesalicylhydroxamic acid

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyridonesPyridines

Study Officials

  • M Safwan Badr, M.D.

    John D. Dingell VA Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

M Safwan Badr, M.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2016

First Posted

October 4, 2016

Study Start

June 9, 2017

Primary Completion

January 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

November 25, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)