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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a sleep treatment can improve sleep and other symptoms for Gulf War Veterans with Gulf War Illness (GWI). The treatment, Apnea and Insomnia Relief (AIR), includes six telehealth sessions focused on sleep education and strategies to manage sleep disorders like apnea (a condition causing breathing to stop and start during sleep) and insomnia (trouble sleeping). Veterans who served in the Gulf War and have sleep problems linked to GWI, along with a diagnosis of obstructive sleep apnea, might be ideal candidates. The goal is to determine if improving sleep also alleviates other GWI symptoms, such as fatigue and mood issues. As an unphased trial, this study offers a unique opportunity to contribute to understanding and improving treatments for Gulf War Illness.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Apnea and Insomnia Relief (AIR) treatment aims to help Gulf War Veterans with sleep issues such as apnea (breathing problems during sleep) and insomnia (difficulty sleeping). This treatment involves learning about sleep, using motivation techniques, and adopting better sleep habits.

While specific safety data for AIR is limited, its components are generally safe and commonly used. One part of AIR, cognitive behavioral therapy for insomnia (CBT-I), is a standard and well-tolerated method. Other elements, like educational sessions and motivational talks, are also safe and widely used in similar programs.

Despite the lack of specific safety data from past studies for AIR, it is reasonable to consider AIR well-tolerated due to its use of established and safe methods to improve sleep. Participants should discuss any concerns with the trial staff to ensure it is a suitable option for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Apnea and Insomnia Relief (AIR) therapy because it combines several innovative approaches to tackle Gulf War Syndrome. Unlike standard treatments, which often focus on sleep aids or medication, AIR incorporates psychoeducation, motivational interviewing, and cognitive behavioral therapy for insomnia (CBT-I), all delivered via telehealth. This method not only addresses the root causes of sleep issues but also promotes better adherence to positive airway pressure (PAP) therapy through personalized strategies. By integrating these elements, AIR offers a comprehensive, non-pharmacological approach that could improve sleep quality for individuals with this condition, potentially leading to better overall health outcomes.

What evidence suggests that this trial's treatments could be effective for Gulf War Syndrome?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) can help veterans with Gulf War Illness (GWI) sleep better and feel better overall. Studies have found that providing CBT-I over the phone improves both sleep and other symptoms of GWI. In this trial, participants may receive the Apnea and Insomnia Relief (AIR) treatment, which includes CBT-I and other methods to promote healthy sleep. Early results suggest this combined approach may help veterans with GWI who have trouble sleeping, potentially leading to better sleep and improved symptoms. Another group in this trial will receive Sleep Education (SE), which covers topics such as the sleep cycle and sleep environment. ^{1 2 4 6 7}

Who Is on the Research Team?

Linda L Chao, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

CDMRP

Collaborator

San Francisco VA Health Care System

Collaborator

Trials

11

Recruited

865,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05137743

Pilot Test of Apnea and Insomnia Relief for Veterans With ...

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 ...

2.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT05137743

Apnea and Insomnia Relief for Veterans With Gulf War Illness

The purpose of this study is to determine whether a behavioral sleep treatment improves sleep and other Gulf War Illness (GWI) symptoms in Gulf ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8217272/

Cognitive behavioral therapy for insomnia in veterans with ...

To examine whether cognitive behavioral therapy for insomnia (CBT-I), delivered by telephone, improves sleep and non-sleep symptoms of Gulf War Illness ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0024320521001326

Cognitive behavioral therapy for insomnia in veterans with ...

To examine whether cognitive behavioral therapy for insomnia (CBT-I), delivered by telephone, improves sleep and non-sleep symptoms of Gulf War Illness (GWI).

5.

clinicaltrials.gov

clinicaltrials.gov/ct2/show/NCT00252629

Sleep Disordered Breathing in Gulf War Illness and the ...

The purpose of this study is to determine any sleep disordered breathing in veterans with Gulf War Syndrome (GWS) and compare it to healthy normal ...

6.

apps.dtic.mil

apps.dtic.mil/sti/trecms/pdf/AD1190889.pdf

Pilot Test of Apnea and Insomnia Relief for Veterans with Gulf ...

This study will investigate whether treating OSA and insomnia in tandem will reduce GWI symptoms and improve quality of life in GW. Veterans with comorbid GWI, ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11166522/

Sleep Apnea Among Gulf War Veterans: An Examination ...

Gulf-war era veterans may be particularly susceptible to OSA with evidence suggesting that veterans with Gulf War syndrome are at higher risk for OSA and report ...