AIR Therapy for Gulf War Syndrome

(GWAIR Trial)

Overseen By Alyssa Indrajaya, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Antidepressants, Anxiolytics, Sleep medications

Disqualifiers: Uncontrolled diabetes, Heart disease, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

80 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 6 7}

How 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. ^{1 2 3 4 8}

Research Team

Linda L Chao, PhD

Principal Investigator

University of California, San Francisco

Eligibility 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.

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

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

Treatment Details

Interventions

• Apnea and Insomnia Relief (AIR)
• Sleep Education (SE)

Trial Overview 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.

Participant Groups

Group I: Apnea and Insomnia Relief (AIR) Experimental Treatment 1 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 Control 1 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.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

San Francisco VA Health Care System

Collaborator

Trials

11

Recruited

865,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

Cognitive Behavioral Therapy for Insomnia (CBT-I) delivered by telephone significantly improved overall Gulf War Illness (GWI) symptoms, including fatigue, cognitive dysfunction, depression, anxiety, and insomnia severity in 85 Gulf War veterans over eight weekly sessions.

The positive effects of CBT-I on GWI symptoms were not only significant but also sustained for at least six months after treatment, indicating its potential as a long-term intervention for veterans suffering from GWI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia in veterans with gulf war illness: Results from a randomized controlled trial. Chao, LL., Kanady, JC., Crocker, N., et al.[2021]

In a study of 98 Gulf War veterans, those with Gulf War Illness (GWI) showed a significantly higher risk for obstructive sleep apnea compared to veterans without GWI, even after controlling for demographic and clinical factors.

Veterans with GWI also experienced greater insomnia severity and poorer sleep quality, indicating that addressing sleep disturbances could be an important part of managing GWI symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia Severity, Subjective Sleep Quality, and Risk for Obstructive Sleep Apnea in Veterans With Gulf War Illness. Chao, LL., Abadjian, LR., Esparza, IL., et al.[2023]

A study of 73 military service members with both insomnia and obstructive sleep apnea showed that cognitive behavioral therapy for insomnia (CBT-I) led to significant improvements in various sleep-related outcomes, including sleep onset latency and sleep efficiency.

Approximately 26% of participants experienced clinically significant improvements in their insomnia symptoms, suggesting that CBT-I is a viable treatment option for this population despite the challenges of comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Among Active Duty Military Personnel Diagnosed With Obstructive Sleep Apnea. Hoyt, T., Lee, MRG., Stolee, JD., et al.[2023]

Veterans with both insomnia and obstructive sleep apnea (COMISA) experienced a worse quality of life compared to those with only obstructive sleep apnea (OSA), highlighting the need for targeted assessment and treatment of insomnia in this population.

After 12 weeks of continuous positive airway pressure (CPAP) treatment, the COMISA group showed no significant improvement in health-related outcomes and had lower adherence to CPAP compared to the OSA-only group, indicating that insomnia may hinder effective treatment of OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbid insomnia and sleep apnea in Veterans with post-traumatic stress disorder. El-Solh, AA., Adamo, D., Kufel, T.[2019]

A brief, preference-based non-medication treatment for insomnia was found to be feasible and acceptable for 41 veterans, leading to significant improvements in sleep quality from moderate insomnia to sub-threshold levels.

The treatment, which included both in-person and telephone sessions, showed large effect sizes for sleep outcomes, with improvements maintained at a 3-month follow-up, suggesting its potential effectiveness in enhancing rehabilitation for veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility test of preference-based insomnia treatment for Iraq and Afghanistan war veterans. Epstein, DR., Babcock-Parziale, JL., Herb, CA., et al.[2013]

A study involving 210 adults with chronic insomnia and poorly controlled asthma will assess the effectiveness of a 9-week Internet-based cognitive-behavioral treatment for insomnia (CBT-I) on improving both sleep and asthma control.

The research aims to explore whether improvements in sleep quality can lead to better asthma management by examining biological markers like airway inflammation, potentially providing a new approach to asthma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial. Shi, X., Buysse, DJ., Ritterband, LM., et al.[2023]

A study involving 23 adults with asthma and insomnia showed that an Internet-based cognitive-behavioral therapy program (SHUTi) was feasible and well-accepted, with 83% completing the program.

Participants reported significant improvements in insomnia severity, sleep quality, asthma control, and asthma-related quality of life after using SHUTi, indicating its potential as an effective treatment for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. Luyster, FS., Ritterband, LM., Sereika, SM., et al.[2021]

In a study of 192 Persian Gulf War veterans, 8.3% were diagnosed with sleep apnea-hypopnea syndrome (SAHS), indicating a notable prevalence of this condition among veterans.

Among those suspected of having SAHS, 15 out of 46 patients showed significant respiratory disturbances during sleep, with common symptoms including fatigue and memory loss, suggesting that SAHS may contribute to the health issues faced by these veterans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep apnea-hypopnea syndrome in a sample of veterans of the Persian Gulf War. Peacock, MD., Morris, MJ., Houghland, MA., et al.[2017]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for insomnia in veterans with gulf war illness: Results from a randomized controlled trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Insomnia Severity, Subjective Sleep Quality, and Risk for Obstructive Sleep Apnea in Veterans With Gulf War Illness. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia Among Active Duty Military Personnel Diagnosed With Obstructive Sleep Apnea. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Comorbid insomnia and sleep apnea in Veterans with post-traumatic stress disorder. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility test of preference-based insomnia treatment for Iraq and Afghanistan war veterans. [2013]

6. United States pubmed.ncbi.nlm.nih.gov

Solving insomnia electronically: Sleep treatment for asthma (SIESTA): A study protocol for a randomized controlled trial. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Internet-Based Cognitive-Behavioral Therapy for Insomnia in Adults With Asthma: A Pilot Study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Sleep apnea-hypopnea syndrome in a sample of veterans of the Persian Gulf War. [2017]