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AIR Therapy for Gulf War Syndrome (GWAIR Trial)

N/A

Recruiting

Led By Linda L Chao, PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Meets the Kansas GWI and CDC Chronic Multisymptom Illness (CMI) case definitions

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

Must not have

Restless Legs Syndrome (RLS) or screening indicative of RLS based on Restless legs syndrome screening questionnaire (RLSSQ)

Prominent suicidal or homicidal ideation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 1 week post-treatment (after 6 weeks).

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether a sleep treatment can improve symptoms in Gulf War Veterans with Gulf War Illness.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the interventions involve behavioral treatments rather than medication, side effects may include discomfort due to changes in sleeping habits or frustration if immediate improvements are not seen. Physical side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I meet the criteria for Gulf War Illness and Chronic Multisymptom Illness.

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I am a Gulf War Veteran aged 48-80 and was deployed in the Gulf Theater.

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I have been diagnosed with sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with Restless Legs Syndrome.

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I have had strong thoughts of harming myself or others.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 1 week post-treatment (after 6 weeks).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 1 week post-treatment (after 6 weeks).

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 1 week post-treatment (after 6 weeks). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Gulf War Illness Symptom Severity Index

Change in Positive Airway Pressure (PAP) Adherence

Positive Airway Pressure (PAP) Adherence

Secondary study objectives

Insomnia Severity Index (ISI)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 5Eligibility criteria met