Clinical trial

Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

Name

1607015110

Description

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

Trial arms

Trial start

2017-06-09

Estimated PCD

2024-05-31

Trial end

2024-06-30

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Acute episodic hypoxia

Supplemental oxygen

Supplemental oxygen therapy for 6 weeks

Arms:

Supplemental oxygen

Trazodone

100mg before bedtime

Arms:

Trazodone or placebo

Placebo

One placebo pill before-bedtime

Arms:

Trazodone or placebo

Sham

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

Arms:

Acute episodic hypoxia, Supplemental oxygen

Size

100

Primary endpoint

Change in Tidal Volume

1 Week

Change in CO2 reserve (Delta-PETCO2-AT)

1 Week

Change in Apnea Hypopnea Index (AHI)

1 week

Change in hypocapnic apneic threshold

1 week

Eligibility criteria

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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

Updated at

2023-11-03

1 organization

2 products

2 indications

Organization

John D. Dingell VA Medical Center

Product

Indication

Indication

Product