Pilot Test of Apnea and Insomnia Relief for Veterans With Gulf War Illness (NCT05137743) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pilot Test of Apnea and Insomnia Relief for Veterans With Gulf War Illness
United States80 participantsStarted 2022-02-15
Plain-language summary
The purpose of this study is to determine whether a behavioral sleep treatment improves sleep and other Gulf War Illness (GWI) symptoms in Gulf War Veterans with GWI.
Who can participate
Age range48 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male and female GW Veterans between the ages of 48-80
* Deployed to the "Gulf Theater of operations," as defined by 38 CFR 3.317
* Meets the Kansas GWI and Centers for Disease Control and Prevention (CDC) Chronic Multisymptom Illness (CMI) case definitions. The Kansas GWI definition requires cases to endorse multiple or moderate-to-severe chronic symptoms in at least three of six symptom domains. These include: i) fatigue/sleep problems, ii) somatic pain, iii) neurological cognitive, mood symptoms, iv) gastrointestinal symptoms, v) respiratory symptoms, and vi) skin abnormalities. Veterans will be excluded from being considered Kansas GWI cases, for purposes of the proposed trial, if they report being diagnosed by a physician with medical or psychiatric conditions that would account for their symptoms or interfere with their ability to report their symptoms. Veterans with current or past history of PTSD or depression in the past 5 years will not be excluded from participation if they have not been hospitalized for these conditions. The CDC CMI case definition requires cases to endorse symptoms in at least two of three symptom clusters. These include: i) fatigability (e.g., feeling fatigue for 24 hours or more after exertion), ii) mood/cognitive symptoms (e.g., feeling depressed, irritable, worried, tense or anxious; difficulty thinking or concentrating, problems finding words, or problems getting to or staying asleep). iii) musculoskeletal pain.
* Meet …
What they're measuring
1
Change in Gulf War Illness Symptom Severity Index
Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks).
2
Change in Gulf War Illness Symptom Severity Index
Timeframe: Change from baseline to 3 months after treatment ends.
3
Change in Positive Airway Pressure (PAP) Adherence
Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks).
4
Positive Airway Pressure (PAP) Adherence
Timeframe: Change from baseline to 3 months after treatment ends.