AIR Sleep Treatment for PTSD-related Sleep Disorders

(AIR Trial)

Overseen By Lizabeth A Goldstein, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: VA Office of Research and Development

Must not be taking: Antidepressants, Anxiolytics, Sleep medications

Disqualifiers: Psychosis, Substance use disorder, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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 help Veterans with PTSD (a mental health condition triggered by traumatic events) achieve better sleep and improve daily functioning. The study compares a new approach called Apnea and Insomnia Relief (AIR) with standard sleep education. AIR combines education about sleep, motivational support, and techniques to improve sleep habits. Veterans diagnosed with both sleep apnea (a condition affecting breathing during sleep) and insomnia, who also experience PTSD symptoms, may be good candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to important advancements in PTSD and sleep disorder treatments.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you should not have started or stopped any antidepressant, anxiety, or sleep medications in the last month, and you should not plan to stop them during the trial.

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

Research shows that the Apnea and Insomnia Relief (AIR) treatment is under study to improve sleep problems in people with PTSD. Early results indicate that treatments combining education about the condition, motivational support, and therapy for insomnia are generally well-tolerated, meaning most people don't experience serious side effects.

Since this trial is in Phase 2, AIR has already passed some initial safety tests. In these early stages, researchers focus on a treatment's safety. So far, similar treatments for sleep issues have not reported major adverse reactions.

In summary, the AIR treatment appears safe for most people based on similar methods. However, it's always important to consult a healthcare provider before joining any trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for PTSD-related sleep disorders?

Researchers are excited about the Apnea and Insomnia Relief (AIR) treatment for PTSD-related sleep disorders because it combines several innovative approaches that set it apart from standard care options like medication and traditional therapy. Unlike other treatments, AIR integrates psychoeducation and cognitive behavioral therapy specifically tailored for insomnia, along with motivational interviewing and strategies to enhance adherence to Positive Airway Pressure (PAP) therapy. This comprehensive and holistic approach not only addresses the psychological aspects of sleep disorders but also emphasizes adherence to effective physical treatments, offering a promising alternative for those who struggle with PTSD-related sleep issues.

What evidence suggests that this trial's treatments could be effective for PTSD-related sleep disorders?

Research has shown that the Apnea and Insomnia Relief (AIR) treatment, included in this trial, can help people with PTSD sleep better. Studies have found that combining therapy for sleep problems with techniques to improve breathing during sleep greatly reduces insomnia symptoms. Many patients have experienced significant improvements in sleep quality and daily life. The treatment also includes education about the condition and support to help patients adhere to their treatment plan. These components work together to address both apnea (when breathing stops and starts during sleep) and insomnia, common in PTSD. Another treatment option in this trial is Sleep Education (SE), which focuses on understanding the sleep cycle, sleep across the lifespan, and the relationship between sleep and daily activities. ^{1 2 5 6 7}

Who Is on the Research Team?

Lizabeth A Goldstein, PhD

Principal Investigator

San Francisco VA Medical Center, San Francisco, CA

Are You a Good Fit for This Trial?

This trial is for Veterans with both sleep apnea and insomnia, who also have PTSD or subthreshold PTSD. Participants must be diagnosed with sleep apnea (Apnea Hypopnea Index of at least 5) and recommended for PAP therapy. They should be willing to attend all sessions, read English well enough for treatment, and not have plans that interfere with regular attendance.

Inclusion Criteria

Willing to attend all treatment and assessment appointments

You have been diagnosed with insomnia according to the DSM-5 guidelines.

I can read, understand, and communicate in English well enough for treatment and assessments.

Exclusion Criteria

I have recently changed or plan to change my medication for depression, anxiety, or sleep.

You do not have a stable place to live.

I have no travel or personal plans that would interfere with regular treatment.

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 via telehealth over six sessions

6 weeks

6 visits (virtual)

Follow-up

Participants are monitored for changes in quality of life, sleep-related functioning, and PTSD symptom severity

3 months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study is testing a behavioral sleep treatment called Apnea and Insomnia Relief (AIR), compared to Sleep Education (SE). The goal is to see if AIR can improve functioning and sleep quality in Veterans suffering from PTSD.

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.

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?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04007796

NCT04007796 | Apnea and Insomnia Relief Study The primary outcome for this study is quality of life. Other outcomes include sleep-related functioning, PTSD symptom severity, insomnia symptom severity, and ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7337559/

Sleep in PTSD: treatment approaches and outcomes - PMC The present review focuses on recent psychotherapeutic, pharmacological, and sleep medicine treatment approaches for sleep disturbances in PTSD.

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.11008

Breathing new life into PTSD-related sleep disorders! Dual orexin receptor antagonists, which may increase REM sleep, have shown some promise in improving both sleep and PTSD symptoms, but concerns ...

4. ptsd.va.gov ptsd.va.gov/professional/treat/cooccurring/sleep_problems_vets.asp

Sleep Problems in Veterans with PTSD Clinical outcomes data have been collected demonstrating large improvements in insomnia over the course of treatment (29,30). VA also released a treatment ...

5. sleephealthjournal.org sleephealthjournal.org/article/S2352-7218(22)00131-0/fulltext

The bi-directional relationship between post-traumatic ... In this large military cohort, findings suggest that PTSD and OSA and/or insomnia are bi-directionally predictive for their development.

6. withpower.com withpower.com/trial/phase-3-stress-disorders-post-traumatic-1-2020-8ef2d

AIR Sleep Treatment for PTSD-related Sleep Disorders ... What is the purpose of this trial? This trial uses video calls to help veterans with PTSD, sleep apnea, and insomnia improve their sleep and daily functioning.

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/sleep-disorder

UCSF Sleep Disorders Clinical Trials — San Francisco Bay ... The purpose of this study is to determine the safety and feasibility of the Magnap magnetic device in the treatment of obstructive sleep apnea ( ...