CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 29 enrolled
Drug / intervention
Nasal CPAP treatment during sleepother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00252629
NCT00252629N/ACompleted

Inspiratory Flow Dynamics During Sleep in Gulf War Syndrome (GWS) and the Effect of Continuous Positive Airway Pressure (CPAP)

US Department of Veterans Affairs·interventional·Posted Nov 11, 2005·Updated Dec 11, 2014

In Brief

A clinical study evaluating Nasal CPAP treatment during sleep for Apnea, Sleep and Chronic Fatigue Syndrome. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 11, 2005
Enrollment StartNov 1, 2005
Primary CompletionOct 1, 2008
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.6 years ago

Interventions

Nasal CPAP treatment during sleepother

After documenting sleep disordered breathing, GWS subject gets randomized to receive either a therapeutic nasal CPAP or a sham nasal CPAP treatment during sleep, GWS symptoms ( fatigue, pain, and cognitive dysfunction) were assessed by a baseline questionnaires and at 3 week period whether on sham or therapeutic CPAP. The change of symptoms in each group will be compared.