Statement of the Problem: Thirty years after the end of the Gulf War (GW), approximately a quarter to a third of Gulf War (GW) Veterans still suffer from the chronic debilitating symptoms of Gulf War Illness (GWI). There is presently no cure for GWI, and only a handful of clinical trials have investigated treatments for GWI. Therefore, this application will meet the FY20 GWIRP Overarching Treatment Challenge of eliminating the health consequences associated with GWI and revolutionizing treatment.

Rationale: (1) Insomnia is a common symptom of GWI that can exacerbate other non-sleep GWI symptoms such as fatigue, pain, mood, cognitive dysfunction. (2)We recently demonstrated that helping Veterans with GWI overcome insomnia with a non-pharmacological behavioral therapy (i.e., cognitive behavioral therapy for insomnia, CBT-I) not only improves sleep, but also alleviates other GWI symptoms (i.e., fatigue, cognitive failures, depression, and anxiety). (3) We have also shown that Veterans with GWI are at greater risk for obstructive sleep apnea (OSA) compared to Veterans without GWI. (4) Continuous Positive Airway Pressure (CPAP) is the gold standard therapy for OSA. (5) There is also suggestive evidence that CPAP therapy can reduce symptoms of fatigue, pain, and cognitive dysfunction in Veterans with GWI and sleep disordered breathing. (6) OSA is commonly comorbid with insomnia, and the presence of OSA together with insomnia decreases CPAP adherence, which can negatively impact treatment and outcomes. Based on these findings, we hypothesize that treating OSA and insomnia in tandem will reduce GWI symptoms and improve quality of life in GW Veterans with comorbid GWI, insomnia, and OSA.

As noted earlier, OSA is commonly comorbid with insomnia, and the presence of both disorders decreases CPAP adherence. This may be especially problematic for Veterans with GWI because this Veteran population is at increased risk for OSA. As is common in clinical insomnia trials, untreated OSA was exclusionary in the Principal Investigator’s (PI’s) recently completed CBT-I trial. Consequently, many GW Veterans who were interested in participating in the trial were ineligible due to untreated OSA or because they were not adherent with CPAP treatment. Because there is suggestive evidence that CPAP therapy may reduce symptoms of GWI, adherent with CPAP may be particularly relevant for Veterans with GWI and comorbid OSA. In this respect, the proposed study fills a critical gap in the field by conducting a proof-of-concept trial to examine the efficacy of an innovative behavioral intervention developed by study co-investigator Dr. Lizabeth Goldstein that treats OSA and insomnia in tandem (i.e., Apnea and Insomnia Relief, AIR). The main components of AIR include psychoeducation and motivational interviewing to help Veterans identify the short-term and long-term benefits of engaging in OSA and insomnia treatment, CPAP adherence strategies, and CBT-I. While these components are based in established strategies from other behavioral interventions, this represents the first time that they are being evaluated in a unified protocol for Veterans with GWI.

Applicability and Accessibility: The PI’s recently completed remote CBT-I trial for Veterans with GWI not only demonstrates the feasibility of remote trials, but the acceptability of remote trials by Veterans with GWI because it eliminates many logistical barriers, such as location and inherent travel demands. Notably, many of these barriers have been cited as causes for sleep care disparity in Veterans with rural residence. Remote trials also afford working GW Veterans an opportunity to participate in research studies that offer novel, innovative treatments for GWI. The proposed study will deliver the AIR intervention remotely via telehealth technology so that we may take advantage of the national recruitment strategy that proved highly successful in the PI’s previous CBT-I trial. We will use home sleep apnea tests to ascertain OSA status in Veterans without prior OSA diagnosis. We will contract with Philips Respironics to deliver and assist Veterans with the remote CPAP setup via telehealth technology with a licensed respiratory therapist.

The short-term impact of the proposed proof-of-concept trial is that it may provide relief from insomnia and OSA and potentially reduce the number and/or severity of GWI symptoms in the Veterans randomized to the active treatment arm. The project timeline for achieving these patient-related outcomes is the 6-week duration of the trial. Because AIR does not involve pharmacological agents and CPAP devices already have FDA approval, if efficacious, the AIR intervention could be rolled out almost immediately to help Veterans with GWI and OSA. Thus, the long-term impact of the proposed trial would be similar to the short-term impact, but on a much larger scale. We can also work with War Related Illness and Injury Study Centers (WRIISC) and the VA’s TeleSleep Program to standardize the AIR intervention to maximize its potential for scalability. The proposed study has the potential to benefit thousands of GW Veterans who were injured as a result of their military service.