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Treatments for Sleep Apnea in Spinal Cord Injury

Phase 4

Recruiting

Led By M Safwan Badr, M.D.

Research Sponsored by John D. Dingell VA Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be older than 18 years old

Must not have

Severe obstructive or restrictive respiratory defect by PFTs or history of tracheostomy

Subjects ≤ 17 yrs old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will explore possible treatments for sleep-disordered breathing in patients who have had a neck injury for more than six months.

Who is the study for?

This trial is for adults aged 18-89 with chronic cervical spinal cord injury (T6 and above), at least 3 months post-injury, who are not on mechanical ventilation. It excludes those with extreme obesity (BMI ≥ 40 kg/m2), under 17 years old, pregnant or lactating women, severe respiratory defects, history of significant head trauma, or advanced organ diseases.

What is being tested?

The study explores treatments for sleep-disordered breathing in patients with cervical spine injuries. Interventions include supplemental oxygen, acute episodic hypoxia treatment, the drug Trazodone versus placebo controls like sham procedures to assess their effectiveness.

What are the potential side effects?

Possible side effects may include discomfort from wearing a mask for oxygen or hypoxia treatment and potential common medication-related effects from Trazodone such as drowsiness, dizziness, dry mouth or blurred vision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a spinal cord injury above T6, it's been over 3 months, and I've never needed a ventilator.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe breathing problems or have had a tracheostomy.

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I am 17 years old or younger.

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I have a serious condition affecting my heart, lungs, metabolism, liver, or kidneys.

Select...

I have had a head injury that caused symptoms or made me pass out.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 week for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Apnea Hypopnea Index (AHI)

Change in CO2 reserve (Delta-PETCO2-AT)

Change in Tidal Volume

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Trazodone or placeboExperimental Treatment2 Interventions

examine the effect of trazodone on breathing during sleep

Group II: Supplemental oxygenExperimental Treatment2 Interventions

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.

Group III: Acute episodic hypoxiaExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

Supplemental oxygen

2010

Completed Phase 2

~180