Apnea and Insomnia Relief (AIR) for Sleep Apnea Syndromes

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
San Francisco VA Medical Center, San Francisco, CA, San Francisco, CA
Sleep Apnea Syndromes+6 More
Apnea and Insomnia Relief (AIR) - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a behavioral sleep treatment improves functioning and sleep in veterans with posttraumatic stress disorder.

See full description

Eligible Conditions

  • Sleep Apnea Syndromes
  • Insomnia Disorder
  • Moral Injury

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Sleep Apnea Syndromes

Study Objectives

This trial is evaluating whether Apnea and Insomnia Relief (AIR) will improve 1 primary outcome and 5 secondary outcomes in patients with Sleep Apnea Syndromes. Measurement will happen over the course of Change from baseline to 3 months after treatment ends.

Week 6
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
Total sleep time (actigraphy-based)
Month 3
Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Insomnia Severity Index (ISI)
World Health Organization Quality of Life (WHOQOL-BREF)
Month 3
CPAP Adherence

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Sleep Apnea Syndromes

Trial Design

2 Treatment Groups

Sleep Education (SE)
1 of 2
Apnea and Insomnia Relief (AIR)
1 of 2
Active Control
Experimental Treatment

This trial requires 80 total participants across 2 different treatment groups

This trial involves 2 different treatments. Apnea And Insomnia Relief (AIR) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Apnea and Insomnia Relief (AIR)
Behavioral
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.
Sleep Education (SE)
Behavioral
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.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: past 7 days, at 3 months after treatment ends
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly past 7 days, at 3 months after treatment ends for reporting.

Closest Location

San Francisco VA Medical Center, San Francisco, CA - San Francisco, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
will be automatically prescribed and given C-PAP therapy Veterans who are diagnosed with sleep apnea at the San Francisco VA Healthcare System and have an Apnea Hypopnea Index of 5 or more on a sleep study will automatically be prescribed and given C-PAP therapy. show original
According to DSM-5, a person must meet certain criteria in order to be diagnosed with posttraumatic stress disorder (PTSD) show original
Meet DSM-5 Criteria for Insomnia Disorder
I am willing to attend all of my appointments for treatment and assessment. show original
The person needs to be literate and have cognition that is sufficient enough to participate in the treatment and assessment. show original

Patient Q&A Section

Can sleep apnea syndromes be cured?

"Results from a recent clinical trial suggests caution in the assertion that there is a cure for [sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea). However, based on data submitted to the American College of Chest Physicians Committee for the Advancement of Sleep Medicine, the consensus is that the medical community is accepting the concept of the sleep apnea concept of treatment for sleep-related breathing disturbances. This group suggests that patients with the syndrome should be asked for their opinions about treatment options, and that clinicians provide options as the best available treatment options. Furthermore, it is suggested that patients with sleep apnea be informed about the risk of cardiovascular events by their physician, because treatment options currently exist in order to decrease the risk of cardiovascular events." - Anonymous Online Contributor

Unverified Answer

What causes sleep apnea syndromes?

"Results from a recent clinical trial demonstrates a significant increase in OSA and associated abnormal sleep architecture in patients evaluated for primary OSAS, compared with subjects without OSA. In the absence of symptoms of OSA, however, it is suggested that OSA be considered, pending further studies, especially in patients with abnormal sleep architecture." - Anonymous Online Contributor

Unverified Answer

What is sleep apnea syndromes?

"Even though sleep apnea syndrome is a clinically well-recognized clinical entity, it is important for physicians to understand the clinical characteristics of sleep apnea syndromes and the clinical significance of sleep apnea syndrome." - Anonymous Online Contributor

Unverified Answer

How many people get sleep apnea syndromes a year in the United States?

"About one in 10 U.S. adults suffers from a sleep apnea syndrome, but how many people use CPAP is unknown. The study results raise a number of questions about the current diagnosis and treatment in the United States of the disorder." - Anonymous Online Contributor

Unverified Answer

What are the signs of sleep apnea syndromes?

"[sleep apnea](https://www.withpower.com/clinical-trials/sleep-apnea) syndromes are more prevalent in women than men with a prevalence of 34.4% (95% CI = 31.0 to 37.6%) in women and 16.6% (95% CI = 13.1 to 20.7%) in men having sleep studies." - Anonymous Online Contributor

Unverified Answer

What are common treatments for sleep apnea syndromes?

"The most common approaches to OSAS may be related to the severity of the OSAS and may also depend on the type of OSAS. Effective approaches to OSAS depend on many factors including type of underlying illness, adherence to the treatment guidelines, and clinical judgment regarding the appropriateness and safety of specific treatments, especially oral appliances. Sleep physicians should be adept at recognizing and addressing possible compliance and adherence barriers associated with the use of oral appliances as well as the risks and benefits of using this treatment modality in the context of their patient's unique clinical picture and concerns." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of apnea and insomnia relief (air)?

"The side effect profiles of each group were similar. In all, about 1 out of 6 patients (16 percent; n=41) experienced insomnia after a sleep study. Apnea patients reported sleeping more (9.7±2.5) than did nonapnea patients (6.5±2.3) after treatment. The strongest self-reported effect of OSA was the improvement of sleeping difficulties (apnea and insomnia) compared with the control group (P< 0.001)." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving apnea and insomnia relief (air)?

"Many people with OSAS experience relief with noninvasive positive airway pressure treatment [a form of sleep-disordered breathing treatment called "nasal continuous positive airway pressure (nCPAP)", or simply "apnea mask treatment"]: the American College of Physicians Guidelines, the American Academy of Sleep Medicine, and both the European and American Sleep Apnea Associations also recommend this treatment for OSAS. Several clinical trials have been conducted to determine the efficacy and applicability of nCPAP treatment when implemented by non-physician health professionals such as health care professionals or sleep technicians. Notably, the U.S. Food and Drug Administration has received no reports of adverse events or reports of undesirable consequences associated with nCPAP." - Anonymous Online Contributor

Unverified Answer

Is apnea and insomnia relief (air) safe for people?

"A 12-months randomized, controlled, unblinded study with a sample size of 2,750 patients using both air- and water-therapy to treat OSA/CAOS. Outcomes measured using OSA and OSA-related quality of life indexes and self-reported sleepiness and mood change before and 12 months after treatment (using the ESAS, Epworth Sleepiness Scale, and PSQI scales). Data from the PSQI demonstrated that, over time, air-therapy reduced sleepiness and improvement in mood in 98% of the patients. Oxygen saturation was also significantly improved in the group receiving air-therapy and this may provide further benefit to sleepiness and mood." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for sleep apnea syndromes?

"Physicians typically don't suspect sleep apnea in their patients and few patients want to participate in clinical trials of treatment for sleep apnea. The key to success was getting patients engaged in discussions about treatment options. When patients felt that treatment for obstructive sleep apnea syndromes would be a better use of their limited health care resources, they were more likely to consider enrollment in a trial." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets sleep apnea syndromes?

"The most common age of SDB patients is early adulthood (18-29 years). The age of diagnosis is highly variable based on the diagnostic criteria used." - Anonymous Online Contributor

Unverified Answer

Is apnea and insomnia relief (air) typically used in combination with any other treatments?

"In general, air use has a significant effect in sleep-related disorder treatment, but there is disagreement on whether the application of air is effective in the treatment of sleep-related disorders. The combination of air and treatment is the most efficient approach to improving sleep quality and quality of life." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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