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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 week

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Apnea Hypopnea Index (AHI)

Change in CO2 reserve (Delta-PETCO2-AT)

Change in Tidal Volume

+1 more

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

Supplemental oxygen

2010

Completed Phase 2

~180

Sham

2013

Completed Phase 3

~2060

Trazodone

FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

John D. Dingell VA Medical CenterLead Sponsor

8 Previous Clinical Trials

676 Total Patients Enrolled

United States Department of DefenseFED

863 Previous Clinical Trials

227,532 Total Patients Enrolled

M Safwan Badr, M.D.Principal InvestigatorJohn D. Dingell VA Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for individuals to still enroll in this experiment?

"According to the clinicaltrials.gov registry, this research is currently open for recruitment and was initially posted on June 9th 2017 with its most recent update taking place October 4th 2022."

Answered by AI

Am I a suitable candidate for participating in this experimental procedure?

"This trial is accepting 100 participants with sleep apnea syndromes aged 18 to 89."

Answered by AI

How does supplemental oxygen benefit patients in many clinical scenarios?

"Supplemental oxygen can be an effective form of therapy for individuals suffering from eating disorders, schizophrenia, and chronic pain."

Answered by AI

Is there any risk associated with using supplemental oxygen for medical treatment?

"The safety rating for supplemental oxygen was 3, as it is a phase 4 trial and has been officially approved."

Answered by AI

Does this research study permit recruitment of individuals over 40 years old?

"The parameters for enrolment in this clinical trial necessitate that the patient must be between 18 and 89 years old. For those younger than 18, there are 180 suitable trials; conversely, 937 studies are accessible to elderly participants."

Answered by AI

Are there other documented investigations related to Supplemental oxygen?

"Currently, the clinical research landscape for Supplemental oxygen contains 6 different active trials. Of these studies, 2 are in Phase 3 of development and have been enrolled at 55 separate locations across Denver Colorado."

Answered by AI

How many participants are actively engaged in this experiment?

"Affirmative. According to the documentation hosted on clinicaltrials.gov, this experiment is actively recruiting candidates; it was initially posted on June 9th 2017 and most recently edited on October 4th 2022. 100 participants are needed from 1 site in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury

2017. "Treatment of Sleep Apnea in Patients With Cervical Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02922894.

All > Apnea > Spinal Cord