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N/A

Therapeutic nasal CPAP for Sleep Apnea

N/A
Waitlist Available
Led By Mohammad Amin, MD
Research Sponsored by US Department of Veterans Affairs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on a full night polysomnogram
Awards & highlights

Summary

The purpose of this study is to determine any sleep disordered breathing in veterans with Gulf War Syndrome (GWS) and compare it to healthy normal asymptomatic Gulf War veterans. This study will also determine the effect of treatment with continuous positive airway pressure on veterans with Gulf War Syndrome. 1. The investigators hypothesize that sleep complaints (insomnia, un-refreshing sleep and daytime fatigue) among GWS patients are related to increased sleep fragmentation secondary to the presence of sleep disordered breathing in GWS patients. 2. The investigators hypothesize that increased collapsibility of the upper airway during sleep with the development of inspiratory flow limitation (IFL) and sleep disordered breathing causes the increased sleep fragmentation in GWS patients. 3. The investigators hypothesize that correction of IFL and sleep disordered breathing in GWS patients will result in an improvement of their sleep quality resulting in an improvement of their sleep complaints and other functional symptoms.

Eligible Conditions
  • Sleep Apnea
  • Chronic Fatigue Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 weeks treatment with either therapeutic or sham cpap
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 weeks treatment with either therapeutic or sham cpap 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 of Fatigue Symptom
The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.
Secondary outcome measures
Change of Cognitive Dysfunction
Change of Pain Complaint

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Therapeutic nasal CPAPActive Control1 Intervention
Comparing change of veterans reported outcomes before and after 3 weeks treatment of therapeutic nasal CPAP with the change on sham nasal CPAP.
Group II: Sham nasal CPAPPlacebo Group1 Intervention
Comparing change of symptoms and veterans reported outcomes before and after treatment of 3 weeks on sham nasal CPAP with the change on therapeutic nasal CPAP

Find a Location

Who is running the clinical trial?

US Department of Veterans AffairsLead Sponsor
872 Previous Clinical Trials
497,960 Total Patients Enrolled
2 Trials studying Sleep Apnea
122 Patients Enrolled for Sleep Apnea
Mohammad Amin, MDPrincipal InvestigatorVA Medical Center, Northport
2 Previous Clinical Trials
102 Total Patients Enrolled
1 Trials studying Sleep Apnea
84 Patients Enrolled for Sleep Apnea
~1 spots leftby Sep 2025