Gulf War IllnessGWAIRNCT05137743
Pilot Test of Apnea and Insomnia Relief for Veterans With Gulf War Illness
A study testing Apnea and Insomnia Relief (AIR) and Sleep Education (SE) in people with Gulf War Illness, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 80 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- Apnea and Insomnia Relief (AIR) and Sleep Education (SE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2022to 11 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 the DSM-5 research diagnostic criteria for insomnia disorder. Unlike other GWI symptoms, we will not require the Veteran's insomnia to have begun during the Gulf War or within one year after leaving the Gulf region. This is because some GWI symptoms may cause veterans to adopt behaviors that lead to sleep problems later. Results from our CBT-I trial in Veterans with GWI suggest that improving sleep also improves non-sleep related symptoms such as fatigue, depression, pain, and psychosocial function. Therefore, we hypothesize that even if insomnia was not one of the original GWI symptoms, improving sleep in veterans with GWI will also improve other GWI-related symptoms.
- Diagnosed with obstructive sleep apnea (OSA) by physician based on polysomnography or evidence of OSA based on an Apnea-Hyponea Index (AHI) or respiratory disturbance index (RDI) that is > or = 5 based on home sleep apnea testing.
- Have access to wireless internet connection at home for remote positive airway pressure (PAP) data capture.
Who cannot join
- Condition(s) that is/are considered exclusionary for the Kansas GWI criteria. For purposes of this trial, this will include medical or psychiatric conditions diagnosed by a physician/psychiatrist that would account for the Veterans' symptoms or interfere with their ability to report their symptoms. Specific exclusionary criteria include medical conditions such as uncontrolled diabetes, heart disease other than hypertension, stroke, lupus, multiple sclerosis, cancer, liver disease, chronic infection, or serious neurological condition (e.g., dementia, brain injury).
- History of any psychiatric disorder with active psychosis or mania in the past 5 years.
- Severe drug or alcohol use disorder within the past 6 months as assessed by the Structured Clinical Interview for DSM-5 (SCID 5). Veterans with moderate drug or alcohol use disorder will be reviewed on a case-by-case basis.
- Prominent suicidal or homicidal ideation.
- Pregnancy, because insomnia will worsen after 8 weeks.
- Restless Legs Syndrome (RLS) or screening indicative of RLS based on Restless legs syndrome screening questionnaire (RLSSQ).
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- Current enrollment in another clinical trial.
- Traumatic brain injury (TBI) will not be exclusionary for the proposed study unless it impacts cognition to a degree that the Veteran cannot complete treatment or homework assignments (this will be determined on a case-by-case basis at PI and therapists' discretion).
- Starting or ending psychotherapy for a sleep disorder or mental health diagnosis within the last one month.
- Starting or ending an antidepressant, anxiolytic, or sleep medication with the last one month will be excluded. Veterans currently receiving benzodiazepine or benzodiazepine receptor agonists, anticonvulsants, atypical antipsychotic medication, or non-SSRI antidepressant medications such as trazodone will be not be excluded provided that they meet the DSM-5 criteria for insomnia disorder, exhibit evidence of OSA, and will remain on the medication(s) throughout the 6-week treatment period and the 3-month follow-up period.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Health Care System
San Francisco, California, 94121
About this study
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.
Read the detailed description
This study is a randomized controlled trial of a behavioral sleep treatment to improve sleep and other symptoms of Gulf War Illness (GWI) in Gulf War (GW) Veterans with GWI, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home) or telephone. The primary outcome for this study is the severity of Gulf War Illness symptom severity. Other outcomes include sleep-related functioning, insomnia symptom severity, and positive airway pressure (PAP) adherence.
- Conditions
- Gulf War Illness
- Being tested
- Apnea and Insomnia Relief (AIR), Sleep Education (SE)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apnea and Insomnia Relief (AIR)Behavioural
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
Sleep Education (SE)Behavioural
This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
| Study group | Role | What they receive |
|---|---|---|
| Apnea and Insomnia Relief (AIR) | Experimental | This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia (CBT-I). Receives: Behavioral: Apnea and Insomnia Relief (AIR) |
| Sleep Education (SE) | Active comparator | This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep. Receives: Behavioral: Sleep Education (SE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gulf War Illness Symptom Severity Index
Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we used the symptom portion of the Kansas Gulf War Military History and Health Questionnaire to query about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal, respiratory, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. To assess current GWI symptoms, participants will be asked about the absence (0), presence, and severity (1=mild; 2=moderate; 3=severe) of the symptoms over the past 2 weeks instead of over the past 6-months. Score range: 0-87; higher scores = more symptoms and/or more severe symptoms.
Measured: Change from baseline to 1 week post-treatment (after 6 weeks).
Change in Gulf War Illness Symptom Severity Index
Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we used the symptom portion of the Kansas Gulf War Military History and Health Questionnaire to query about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal, respiratory, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. To assess current GWI symptoms, participants will be asked about the absence (0), presence, and severity (1=mild; 2=moderate; 3=severe) of the symptoms over the past 2 weeks instead of over the past 6-months. Score range: 0-87; higher scores = more symptoms and/or more severe symptoms.
Measured: Change from baseline to 3 months after treatment ends.
Change in Positive Airway Pressure (PAP) Adherence
PAP adherence will be measured via PAP device data capture. The average hours of PAP use will be measured from session 1 through post-treatment.
Measured: Change from baseline to 1 week post-treatment (after 6 weeks).
Positive Airway Pressure (PAP) Adherence
PAP adherence will be measured via PAP device data capture. The average hours of PAP use will be measured for 1 week at the follow-up 3 months after treatment ends.
Measured: Change from baseline to 3 months after treatment ends.
Secondary outcomes (2)
Insomnia Severity Index (ISI)
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Measured: Change from baseline to 1 week post-treatment (after 6 weeks).
Insomnia Severity Index (ISI)
This seven-item self-report scale assesses severity of insomnia. Responses to items range from 0 to 4. Total scores range from 0 to 28. Higher scores indicate greater symptom severity.
Measured: Change from baseline to 3 months after treatment ends.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start15 Feb 2022
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco VA Health Care System, United States Department of Defense, Congressionally Directed Medical Research Programs
- Responsible party
- Sponsor
- Investigators
- Linda L Chao, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137743
- Sponsor's protocol ID
- 21-33521
- Other IDs
- CDMRP - GW200046
- Acronym
- GWAIR
- Status last verified
- Jun 2026
- First submitted
- 16 Nov 2021
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chao LL, Kanady JC, Crocker N, Straus LD, Hlavin J, Metzler TJ, Maguen S, Neylan TC. Cognitive behavioral therapy for insomnia in veterans with gulf war illness: Results from a randomized controlled trial. Life Sci. 2021 Aug 15;279:119147. doi: 10.1016/j.lfs.2021.119147. Epub 2021 Feb 4.
PubMed 33549595
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of Apnea and Insomnia Relief for Veterans With Gulf War Illness
- ClinicalTrials.gov ID
- NCT05137743
- Acronym / sponsor ID
- GWAIR / 21-33521
- Conditions
- Gulf War Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco VA Health Care System, United States Department of Defense, Congressionally Directed Medical Research Programs
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 30 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a randomized controlled trial of a behavioral sleep treatment to improve sleep and other symptoms of Gulf War Illness (GWI) in Gulf War (GW) Veterans with GWI, sleep apnea, and insomnia. The treatment is delivered via telehealth (video to home) or telephone. The primary outcome for this study is the severity of Gulf War Illness symptom severity. Other outcomes include sleep-related functioning, insomnia symptom severity, and positive airway pressure (PAP) adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with participants assigned to one of two treatment groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Apnea and Insomnia Relief (AIR) | Experimental | Behavioral: Apnea and Insomnia Relief (AIR)This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia (CBT-I). |
| Sleep Education (SE) | Active comparator | Behavioral: Sleep Education (SE)This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep. |
Who may qualify
- Ages
- 48 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 the DSM-5 research diagnostic criteria for insomnia disorder. Unlike other GWI symptoms, we will not require the Veteran's insomnia to have begun during the Gulf War or within one year after leaving the Gulf region. This is because some GWI symptoms may cause veterans to adopt behaviors that lead to sleep problems later. Results from our CBT-I trial in Veterans with GWI suggest that improving sleep also improves non-sleep related symptoms such as fatigue, depression, pain, and psychosocial function. Therefore, we hypothesize that even if insomnia was not one of the original GWI symptoms, improving sleep in veterans with GWI will also improve other GWI-related symptoms.
- Diagnosed with obstructive sleep apnea (OSA) by physician based on polysomnography or evidence of OSA based on an Apnea-Hyponea Index (AHI) or respiratory disturbance index (RDI) that is > or = 5 based on home sleep apnea testing.
Key exclusion criteria (10 listed)
- Condition(s) that is/are considered exclusionary for the Kansas GWI criteria. For purposes of this trial, this will include medical or psychiatric conditions diagnosed by a physician/psychiatrist that would account for the Veterans' symptoms or interfere with their ability to report their symptoms. Specific exclusionary criteria include medical conditions such as uncontrolled diabetes, heart disease other than hypertension, stroke, lupus, multiple sclerosis, cancer, liver disease, chronic infection, or serious neurological condition (e.g., dementia, brain injury).
- History of any psychiatric disorder with active psychosis or mania in the past 5 years.
- Severe drug or alcohol use disorder within the past 6 months as assessed by the Structured Clinical Interview for DSM-5 (SCID 5). Veterans with moderate drug or alcohol use disorder will be reviewed on a case-by-case basis.
- Prominent suicidal or homicidal ideation.
- Pregnancy, because insomnia will worsen after 8 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apnea and Insomnia Relief (AIR)This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia. | Behavioural | Apnea and Insomnia Relief (AIR) |
| Sleep Education (SE)This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep. | Behavioural | Sleep Education (SE) |
Primary outcome
Change in Gulf War Illness Symptom Severity Index
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks).
Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we used the symptom portion of the Kansas Gulf War Military History and Health Questionnaire to query about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal, respiratory, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. To assess current GWI symptoms, participants will be asked about the absence (0), presence, and severity (1=mild; 2=moderate; 3=severe) of the symptoms over the past 2 weeks instead of over the past 6-months. Score range: 0-87; higher scores = more symptoms and/or more severe symptoms.
Change in Gulf War Illness Symptom Severity Index
Time frame: Change from baseline to 3 months after treatment ends.
Due to its novelty, complexity, and variability, no single measure of severity addresses all possible presentations of Gulf War Illness (GWI). Therefore, we used the symptom portion of the Kansas Gulf War Military History and Health Questionnaire to query about fatigue/sleep problems, somatic pain, skin abnormalities, gastrointestinal, respiratory, and neurologic/cognitive/mood symptoms, based on the Kansas GWI and CDC CMI case definition. To assess current GWI symptoms, participants will be asked about the absence (0), presence, and severity (1=mild; 2=moderate; 3=severe) of the symptoms over the past 2 weeks instead of over the past 6-months. Score range: 0-87; higher scores = more symptoms and/or more severe symptoms.
Change in Positive Airway Pressure (PAP) Adherence
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks).
PAP adherence will be measured via PAP device data capture. The average hours of PAP use will be measured from session 1 through post-treatment.
Positive Airway Pressure (PAP) Adherence
Time frame: Change from baseline to 3 months after treatment ends.
PAP adherence will be measured via PAP device data capture. The average hours of PAP use will be measured for 1 week at the follow-up 3 months after treatment ends.
2 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: Change from baseline to 1 week post-treatment (after 6 weeks).
Insomnia Severity Index (ISI)
Time frame: Change from baseline to 3 months after treatment ends.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 33549595Chao LL, Kanady JC, Crocker N, Straus LD, Hlavin J, Metzler TJ, Maguen S, Neylan TC. Cognitive behavioral therapy for insomnia in veterans with gulf war illness: Results from a randomized controlled trial. Life Sci. 2021 Aug 15;279:119147. doi: 10.1016/j.lfs.2021.119147. Epub 2021 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda L Chao, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apnea and Insomnia Relief (AIR) and Sleep Education (SE) in people with Gulf War Illness, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gulf War Illness Symptom Severity Index (time frame: Change from baseline to 1 week post-treatment (after 6 weeks).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05137743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.