Sleep Disordered Breathing in Gulf War Syndrome Veterans and the Effect of Continuous Positive Airway Pressure (CPAP) Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00252629
First received: November 9, 2005
Last updated: February 6, 2012
Last verified: February 2012
  Purpose

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 in GWS patients.
  2. The investigators 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. The investigators 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
Apnea, Sleep
Chronic Fatigue Syndrome
Procedure: CPAP treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Inspiratory Flow Dynamics During Sleep in Gulf War Syndrome (GWS) and the Effect of Continuous Positive Airway Pressure (CPAP)

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Objective 1: The arousal indices and sleep stage shifts (mean + standard deviation [SD]) reported for GWS patients and GW normals [ Time Frame: during the first polysomnography ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective 2: The prevalence of flow limited breaths during sleep in GWS patients [ Time Frame: during the second polysomnography ] [ Designated as safety issue: No ]
  • Objective 3: The assumption that the investigators will observe a 50% decrease in fatigue and sleep problems and a 45% decrease in pain in patients with GWS (from their preliminary GWS patients pilot study) [ Time Frame: on the second polysomnography ] [ Designated as safety issue: No ]
  • the postulated placebo response is a 10% decrease. [ Time Frame: improvement of symptoms for whom on therapeutic CPAP compared to whom on sham CPAP ] [ Designated as safety issue: No ]

Enrollment: 44
Study Start Date: November 2005
Study Completion Date: November 2010
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: 1
comparing symptoms improvement on therapeutic CPAP compared to sham CPAP
Procedure: CPAP treatment
After documenting sleep disordered breathing, GWS subject gets randomized to receive either a therapeutic CPAP or a sham CPAP, GWS symptoms ( fatigue, cognitive dysfunction and pain) gets assessed by a baseline questionnaires and at 3 week period whether on sham or effective CPAP

Detailed Description:

Hypothesis 1: To demonstrate that compared to Gulf War Veterans without GWS, GWS patients have decreased total sleep and increased sleep fragmentation

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 the 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.

  Eligibility

Ages Eligible for Study:   32 Years to 52 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252629

Locations
United States, New York
VA Medical Center, Northport
Northport, New York, United States, 11768
Sponsors and Collaborators
Investigators
Principal Investigator: Mohammad Amin, MD VA Medical Center, Northport
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00252629     History of Changes
Other Study ID Numbers: RCD-001-05S
Study First Received: November 9, 2005
Last Updated: February 6, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Fatigue
Functional Somatic Syndrome
Gulf War Syndrome
Sleep apnea
Upper Airway Resistance Syndrome

Additional relevant MeSH terms:
Apnea
Fatigue
Fatigue Syndrome, Chronic
Sleep Apnea Syndromes
Persian Gulf Syndrome
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Occupational Diseases

ClinicalTrials.gov processed this record on April 16, 2014