Sleep Disordered Breathing in Gulf War Illness and the Effect of Nasal CPAP Treatment

NCT00252629 | Completed Results DMC

• 1 other identifier: RCD-001-05S
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.

Conditions

Apnea, Sleep; Chronic Fatigue Syndrome

Keywords

Fatigue; Functional Somatic Syndrome; Gulf War Syndrome; Sleep apnea; Upper Airway Resistance Syndrome

Outcome Measures

Primary Outcomes (2)

• Change of Fatigue Symptom

  Fatigue- increasing impact was rated 1-7 using the fatigue severity scale on days 1 and 7 averaged, where 1= no fatigue and 7= severe fatigue.

  3 weeks treatment with either therapeutic or sham CPAP

• The Prevalence of Inspiratory Flow Limitation (IFL) During Sleep in GWS.

  IFL was determined by plotting inspiratory flow against supra-glottic pressure for each breath sampled during continuous stage 2 sleep on a full night polysomnogram on both veterans with GWS and asymptomatic gulf war veterans. We expressed the prevalence of inspiratory flow limitations during sleep as the percentage of flow limited breath in the sample of both GWS and asymptomatic gulf was veterans.

  On a full night polysomnogram

Secondary Outcomes (2)

• Change of Pain Complaint

  3 weeks of treatment on either therapeutic or sham nasal CPAP

• Change of Cognitive Dysfunction

  3 weeks treatment with either therapeutic or sham CPAP

Study Arms (2)

Therapeutic nasal CPAP

ACTIVE COMPARATOR

Comparing change of veterans reported outcomes before and after 3 weeks treatment of therapeutic nasal CPAP with the change on sham nasal CPAP.

Other: Nasal CPAP treatment during sleep

Sham nasal CPAP

SHAM COMPARATOR

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

Other: Nasal CPAP treatment during sleep

Interventions

Nasal CPAP treatment during sleep OTHER

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.

Sham nasal CPAP; Therapeutic nasal CPAP

Eligibility Criteria

• Age: 32 Years - 52 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• Females
• History of active alcoholism or opiate drug use
• History of active depression and PTSD

Sponsors & Collaborators

• US Department of Veterans Affairs: lead

Study Sites (1)

VA Medical Center, Northport

Northport, New York, 11768, United States

Location

Related Publications (2)

• Amin MM, Gold MS, Broderick JE, Gold AR. The effect of nasal continuous positive airway pressure on the symptoms of Gulf War illness. Sleep Breath. 2011 Sep;15(3):579-87. doi: 10.1007/s11325-010-0406-8. Epub 2010 Aug 19.

  PMID: 20717848 RESULT

• Amin MM, Belisova Z, Hossain S, Gold MS, Broderick JE, Gold AR. Inspiratory airflow dynamics during sleep in veterans with Gulf War illness: a controlled study. Sleep Breath. 2011 Sep;15(3):333-9. doi: 10.1007/s11325-010-0386-8. Epub 2010 Aug 12.

  PMID: 20703820 RESULT

MeSH Terms

Conditions

Sleep Apnea Syndromes; Fatigue Syndrome, Chronic; Fatigue; Persian Gulf Syndrome

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Occupational Diseases; War-Related Injuries; Wounds and Injuries

Results Point of Contact

• Title: Mohammad M. Amin, MD
• Organization: Northport, VAMC

mohammad.amin2@va.gov

6312614400

Study Officials

• Mohammad Amin, MD

  VA Medical Center, Northport

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2005
• First Posted: November 11, 2005
• Study Start: November 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: November 1, 2010
• Last Updated: December 11, 2014
• Results First Posted: December 11, 2014

Record last verified: 2014-12

Locations

US (1)