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 .Also determine the effect of treatment with Continuous Positive Airway Pressure on Veterans with Gulf War Syndrome .

1. We hypothesize that sleep complaints (insomnia, un-refreshing sleep and daytime fatigue) among GWS patients are related to increased sleep fragmentation in GWS patients (1).
2. We hypothesize that increased collapsibility of the upper airway during sleep with the development of inspiratory flow limitation (IFL) causes the increased sleep fragmentation in GWS patients.
3. We hypothesize that correction of IFL in GWS patients will result in an improvement of their sleep quality resulting in an improvement of their sleep complaints and other functional symptoms.

Condition	Intervention
Gulf War Syndrome Chronic Fatigue Syndrome Functional Somatic Syndrome Upper Airway Resistance Syndrome Sleep Apnea	Procedure: CPAP treatment

Further study details as provided by Department of Veterans Affairs:

Primary Outcomes: Objective 1: The arousal indices and sleep stage shifts (mean +SD) reported for GWS patients and GW normals .; Objective 2: The prevalence of flow limited breaths during sleep in GWS patients.; Objective 3. The assumption that we will observe a 50% decrease in fatigue and sleep problems and a 45% decrease in pain in patients with GWS(from our preliminary GWS patients pilot study). The postulated placebo response is a 10% decrease.
Expected Total Enrollment:  44

Hypothesis 1 To demonstrate that compared to Gulf War Veterans without GWS, GWS patients have decreased total sleep and increased sleep fragmentation (2):In order to accomplish this goal and subsequent goals, we will assemble two samples of Gulf War veterans. The first will be a sample of male GWS patients and the second will be a sample of male Gulf War veterans without GWS (Gulf War veteran control group). All of the GWS patients will be registered in the Gulf War Veterans Registry. To avoid referral bias favoring the presence of IFL during sleep, we will enroll GWS patients by contacting them from the Registry and inviting them to participate. Gulf War veteran controls will be recruited in the same way and by advertisement. Prospective study participants will be screened on several self-report instruments to determine eligibility and assignment to the GWS group or to the Gulf War veteran control group. Criteria for assignment to GWS group are scores above the designated clinical cutpoint on each of three instruments measuring cognitive difficulties, pain, and fatigue. Conversely, criteria for assignment to the GW Veteran control group will require scores in the non-clinical range on each of those instruments. Every subject will have a full night polysomnogram.

Hypothesis 2: To demonstrate that the presence of IFL during sleep among GWS patients distinguishes them from Gulf War veterans without GWS A second sleep study will be used to accomplish this second objective. Using precise methods, we will quantify the prevalence of IFL during sleep in GWS patients and in Gulf War veteran controls.Following completion, each study will be staged using Rechtschaffen and Kales criteria. From each study, 3 three minute periods of continuous NREM sleep (a total of approximately 120 breaths) will be randomly selected and analyzed for the prevalence of flow limited breaths. During the three minute periods, all of the breaths will be analyzed whether they occur during sleep or during brief (< 15 second) arousals.

Hypothesis 3: To demonstrate that relief of IFL during sleep will result in improvement of the functional symptoms of GWS patients. We will accomplish this utilizing a double blind, placebo-controlled trial of nasal continuous positive airway pressure (CPAP) in GWS patients. Functional symptoms will be assessed using validated, self-report questionnaires and daily ratings of symptoms with an electronic diary.

Ages Eligible for Study:  32 Years   -   52 Years,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• 1.First Gulf War Veterans with and without the syndrome. 2.Male. 3.Between 32 and 52 years of age. 4.No history of current alcoholism nor opiate use 5.No history of current active depression nor PTSD

Exclusion Criteria:

• 1.Female 2.history of active alcoholism or opiate drug use 3.history of active depression and PTSD

Please refer to this study by ClinicalTrials.gov identifier  NCT00252629

Mohammad Amin, MD      631-261-4400  Ext. 2469    mohammad.amin2@med.va.gov
Pamela Jannello      631-261-4400  Ext. 2475    pamela.jannello@med.va.gov

New York
      VAMC - Northport, NY, Northport,  New York,  11768,  United States

Study chairs or principal investigators

Mohammad Amin, MD,  Principal Investigator,  VAMC - North port, NY   

Study ID Numbers:  RCD-001-05S
Last Updated:  December 8, 2005
Record first received:  November 9, 2005
ClinicalTrials.gov Identifier:  NCT00252629
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-10