N/A
N=29
Sleep Disordered Breathing in Gulf War Illness and the Effect of Nasal CPAP Treatment
Apnea, Sleep · Chronic Fatigue Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT00252629 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Dec 2014
Primary outcome: Primary: Change of Fatigue Symptom — 2.1; 0.2 units on a scale — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal CPAP treatment during sleep (Other)
- Age
- Adult · 32+ yrs
- Sex
- Male
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Fatigue Symptom |
2.1; 0.2 | 0.0002 sig |
| PRIMARY The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS. |
96; 36 | 0.0001 sig |
| SECONDARY Change of Pain Complaint |
2.0; 0.4 | 0.0008 sig |
| SECONDARY Change of Cognitive Dysfunction |
2.0; 0.4 | 0.004 sig |
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.
Eligibility Criteria
Inclusion Criteria
- First Gulf War veterans with and without the syndrome
- Males
- Between 32 and 52 years of age
- No history of current alcoholism nor opiate use
- No history of current active depression nor post-traumatic stress disorder (PTSD)
Exclusion Criteria
- Females
- History of active alcoholism or opiate drug use
- History of active depression and PTSD
Data sourced from ClinicalTrials.gov (NCT00252629). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.