AIR Therapy for Gulf War Syndrome
(GWAIR Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, San Francisco
Must not be taking: Antidepressants, Anxiolytics, Sleep medications
Disqualifiers: Uncontrolled diabetes, Heart disease, Stroke, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stay on your current medications if you are taking benzodiazepines, anticonvulsants, atypical antipsychotics, or certain antidepressants like trazodone, as long as you meet the criteria for insomnia disorder and have sleep apnea. You should not start or stop any antidepressant, anxiety, or sleep medications within one month before joining the trial.
What data supports the effectiveness of the treatment for Gulf War Syndrome?
Research shows that cognitive behavioral therapy for insomnia (CBT-I) can improve sleep and other symptoms in veterans with Gulf War Illness when delivered by phone. Additionally, veterans with Gulf War Illness often have sleep issues like insomnia and sleep apnea, suggesting that treatments targeting these problems, like CBT-I, could be beneficial.
12345Is AIR Therapy safe for humans?
Cognitive Behavioral Therapy for Insomnia (CBT-I), which is similar to AIR Therapy, has been studied in various groups, including veterans and people with asthma, and is generally considered safe. Participants in these studies have reported positive experiences without significant safety concerns.
12367How is the AIR treatment for Gulf War Syndrome different from other treatments?
The AIR treatment is unique because it combines behavioral sleep therapy specifically targeting both apnea (breathing interruptions during sleep) and insomnia (difficulty sleeping), which are common in Gulf War Syndrome. This approach is novel as it addresses both conditions simultaneously, unlike other treatments that typically focus on one or the other.
12348Eligibility Criteria
This trial is for Gulf War Veterans aged 48-80 with Gulf War Illness (GWI) who have sleep disorders like insomnia and obstructive sleep apnea, confirmed by a doctor. Participants must meet specific GWI criteria, have internet at home, and not be involved in other trials or starting/stopping certain medications or therapies within the last month.Inclusion Criteria
I meet the criteria for Gulf War Illness and Chronic Multisymptom Illness.
Have access to wireless internet connection at home for remote positive airway pressure (PAP) data capture
I am a Gulf War Veteran aged 48-80 and was deployed in the Gulf Theater.
+2 more
Exclusion Criteria
I have been diagnosed with Restless Legs Syndrome.
I haven't started or stopped any medication for depression, anxiety, or sleep in the last month.
Pregnancy
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive behavioral sleep treatment over six sessions via telehealth or telephone
6 weeks
6 visits (virtual)
Follow-up
Participants are monitored for changes in Gulf War Illness symptom severity and PAP adherence
3 months
Participant Groups
The study tests if a behavioral treatment called Apnea and Insomnia Relief (AIR) can improve sleep and other symptoms of GWI compared to just Sleep Education (SE). It's designed to see which method is more effective for veterans suffering from these conditions.
2Treatment groups
Experimental Treatment
Active Control
Group I: Apnea and Insomnia Relief (AIR)Experimental Treatment1 Intervention
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).
Group II: Sleep Education (SE)Active Control1 Intervention
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
VA Health Care SystemSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
San Francisco VA Health Care SystemCollaborator
United States Department of DefenseCollaborator
References
Cognitive behavioral therapy for insomnia in veterans with gulf war illness: Results from a randomized controlled trial. [2021]To examine whether cognitive behavioral therapy for insomnia (CBT-I), delivered by telephone, improves sleep and non-sleep symptoms of Gulf War Illness (GWI).
Insomnia Severity, Subjective Sleep Quality, and Risk for Obstructive Sleep Apnea in Veterans With Gulf War Illness. [2023]Despite the fact that sleep disturbances are common in veterans with Gulf War Illness (GWI), there has been a paucity of published sleep studies in this veteran population to date. Therefore, the present study examined subjective sleep quality (assessed with the Pittsburgh Sleep Quality Index), insomnia severity (assessed with the Insomnia Severity Index), and risk for obstructive sleep apnea (assessed with the STOP questionnaire) in 98 Gulf War veterans. Veterans with GWI, defined either by the Kansas or Centers for Disease Control and Prevention criteria, had greater risk for obstructive sleep apnea (i.e., higher STOP scores) than veterans without GWI. This difference persisted even after accounting for potentially confounding demographic (e.g., age, gender) and clinical variables. Veterans with GWI, defined by either the Kansas or Centers for Disease Control and Prevention criteria, also had significantly greater insomnia severity and poorer sleep quality than veterans without GWI (p
Cognitive Behavioral Therapy for Insomnia Among Active Duty Military Personnel Diagnosed With Obstructive Sleep Apnea. [2023]Insomnia and obstructive sleep apnea are common conditions among military service members, with high rates of comorbidity. Although cognitive behavioral therapy for insomnia (CBT-I) has been established as an effective treatment for insomnia, it is unclear whether or not CBT-I is effective among service members with comorbid insomnia and obstructive sleep apnea.
Comorbid insomnia and sleep apnea in Veterans with post-traumatic stress disorder. [2019]The purpose of this study was to determine the impact of insomnia in Veterans with post-traumatic stress disorder (PTSD) and obstructive sleep apnea (OSA) on health-related outcomes before and after 12 weeks of continuous positive airway pressure (CPAP) treatment.
Feasibility test of preference-based insomnia treatment for Iraq and Afghanistan war veterans. [2013]The study determined the feasibility of implementing a brief, preference-based non-medication insomnia treatment for Iraq/Afghanistan war Veterans who experienced blast and/or other injuries resulting in an altered level of consciousness.
Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial. [2023]Chronic insomnia is associated with poor asthma control. Cognitive-behavioral treatment for insomnia (CBT-I) is an efficacious and durable treatment for comorbid insomnia in medical and psychiatric disorders. However, the efficacy and potential accompanying mechanisms of CBT-I have not been examined in asthma. The purpose of this study is to test the efficacy of a CBT-I intervention on sleep and asthma control in adults with insomnia and asthma. We will also explore airway inflammation (i.e., exhaled nitric oxide, blood eosinophils) as a potential biological mechanism linking improvements in sleep with improvements in asthma control.
Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. [2021]Background/Objective: Insomnia is common among adults with asthma and is associated with worse asthma control. Cognitive-behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia with medical comorbidities, but it has not been tested in asthma. The purpose of this study was to assess the feasibility and acceptability of an Internet-based CBT-I intervention, called Sleep Healthy Using the Internet (SHUTi), among adults with asthma and comorbid insomnia, and to gather preliminary efficacy data on changes in insomnia severity, sleep quality, asthma control, and asthma-related quality of life. Methods: A single-group, pretest-posttest design was employed, where all participants completed the SHUTi program. Online questionnaires were completed pre- and postintervention. Individual telephone interviews were conducted after posttreatment data collection to obtain participants' experiences with SHUTi and suggestions for improvement. Results: The sample (N = 23) comprised men and women aged 18-75 years with moderate to severe, not well-controlled asthma, and comorbid insomnia. Nineteen (83%) completed postintervention assessments. Improvements on the Insomnia Severity Index, Pittsburgh Sleep Quality Index, Asthma Control Test, and Asthma Quality of Life Questionnair-Marks were observed at postintervention. Data from the telephone interviews suggest that most participants had a positive experience with SHUTi. Participants suggested incorporating asthma-specific content into future versions of the intervention. Conclusions: Internet-based CBT-I is a potential treatment option for adults with asthma and comorbid insomnia.
Sleep apnea-hypopnea syndrome in a sample of veterans of the Persian Gulf War. [2017]The prevalence of sleep apnea-hypopnea syndrome (SAHS) was investigated in a selected group of veterans of the Persian Gulf War at Brooke Army Medical Center. One hundred ninety-two self-referred patients participated in the full evaluation of the Comprehensive Clinical Evaluation Program (CCEP) for veterans of the Persian Gulf War. After completing an initial survey, an interview and examination were performed by staff internists. Forty-six participants with histories suggestive of a sleep disorder were referred for further evaluation. Those patients suspected of SAHS then completed a sleep disorders questionnaire and underwent standard nocturnal polysomnography (PSG). SAHS was defined as a respiratory disturbance index > or = 15 in a symptomatic patient. Fifteen of 46 patients undergoing PSG at this institution met criteria for SAHS. The majority of these patients had symptoms of fatigue and memory loss. Overall, 16 of the 192 patients (8.3%) in the CCEP of our institution were diagnosed with SAHS. SAHS may play a significant role in the symptom complex presented by many veterans of the Persian Gulf War.