CompletedNot Applicable

Pilot Test of Apnea and Insomnia Relief for Veterans With Gulf War Illness

United States118 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 range

48 Years – 80 Years

Sex

ALL

See this in plain English?

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial was specifically for Veterans with Gulf War Illness who also had sleep apnea — do you think my particular combination of Gulf War Illness symptoms and sleep issues would have made me a good fit for something like this, and does that tell us anything about what treatments might help me?
2Since this was a pilot study with no assigned phase, what does that mean about how much we can trust the results — and has any follow-up research come out of it that might be more conclusive?
3The trial was measuring both Gulf War Illness symptom severity and how well people stuck with their PAP therapy — does that suggest there's a real connection between treating sleep apnea and improving Gulf War Illness symptoms overall, and is that worth exploring in my care?
4Since this trial is now completed, would it be worth trying to find the published results, and could those findings change how you'd approach treating my sleep problems alongside my Gulf War Illness?
5Are there currently any active trials or standard treatment approaches for Gulf War Illness that combine sleep apnea treatment with broader symptom management, similar to what this study was testing?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Gulf War Illness Symptom Severity Index

Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks).

Change in Gulf War Illness Symptom Severity Index

Timeframe: Change from baseline to 3 months after treatment ends.

Change in Positive Airway Pressure (PAP) Adherence

Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks).

Positive Airway Pressure (PAP) Adherence

Timeframe: Change from baseline to 3 months after treatment ends.

Trial details

NCT IDNCT05137743

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-11

View on ClinicalTrials.gov More Gulf War Illness trials

Who can participate

Age range

48 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Gulf War Illness Symptom Severity Index

Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks).

Change in Gulf War Illness Symptom Severity Index

Timeframe: Change from baseline to 3 months after treatment ends.

Change in Positive Airway Pressure (PAP) Adherence

Timeframe: Change from baseline to 1 week post-treatment (after 6 weeks).

Positive Airway Pressure (PAP) Adherence

Timeframe: Change from baseline to 3 months after treatment ends.