Digital CBTI hubs as a treatment augmentation strategy in military clinics: study protocol for a pragmatic randomized clinical trial.

BACKGROUND: Chronic insomnia is the most prevalent sleep disorder among military service members, and it compromises readiness, performance, and physical and mental health. Cognitive behavioral treatment for insomnia (CBTI) is the standard of care for the treatment of insomnia recommended by the VA/DoD Clinical Practice Guideline, the American Academy of Sleep Medicine, and the American College of Physicians. CBTI is highly effective but has limited scalability. It is often unavailable in clinical settings where service members receive sleep care. Digital technologies offer unique opportunities to scale and broaden the geographic reach of CBTI services and support increased patient access and engagement in behavioral sleep care. This study aims to evaluate the impact and acceptability of digital CBTI hubs to augment military treatment facilities' capabilities in behavioral sleep medicine. METHODS: This is a multi-site, non-inferiority randomized clinical trial designed to compare the effects of in-person (face-to-face or virtual) insomnia care as usual at three military sleep clinics versus CBTI delivered remotely and asynchronously through digital CBTI hubs. Digital CBTI hubs are led by licensed, certified clinicians who use NOCTEM's® evidence-based clinical decision support platform COAST™ (Clinician Operated Assistive Sleep Technology). Changes in insomnia severity and daytime symptoms of depression and anxiety will be compared at baseline, at 6-8 weeks, and at 3-month follow-up. Patient satisfaction with insomnia care as usual versus digital CBTI hubs will also be examined. We hypothesize that digital CBTI hubs will be non-inferior to insomnia care as usual for improvements in insomnia and daytime symptoms as well as patient satisfaction with insomnia care. DISCUSSION: Digital technology has a high potential to scale CBTI accessibility and delivery options required to meet the insomnia care needs of military service members. Digital CBTI hubs using COAST offer a novel approach to broaden service members' access to CBTI and to serve as an augmentation strategy for existing sleep services at military treatment facilities. The pragmatic approach leveraging technology in this trial has the potential to rapidly inform clinical practice within the Defense Health Agency as well as other healthcare systems. TRIAL REGISTRATION: ClinicalTrials.gov NCT05490550. Registered on 14 July 2023.

The Success of Oral Appliance Therapy Based on Symptom-Driven Titration.

STUDY OBJECTIVE: Obstructive sleep apnea (OSA) is a chronic condition that could lead to debilitating and sometimes life-threatening consequences. Oral appliance therapy (OAT) is effective in providing a conservative, nonsurgical treatment option for patients diagnosed with mild-to-moderate OSA. The primary goal of this study is to describe a symptom-based titration protocol and determine if the patients can be effectively managed with oral appliances (OAs). METHOD: A retrospective chart review of patients who were treated with OAs was analyzed for the management of OSA. Patients were self-titrated for symptomatic improvement before posttreatment titration sleep studies were conducted. RESULTS: Our study has found that 87.5% of the test population was successfully managed with OAs after overnight titration. Seventy-five percentage of the patients were titrated to Apnea-Hypopnea Index (AHI) < 5 with an average of 79.6% reduction from the baseline. Statistical studies showed that patients' body mass index and age at baseline polysomnogram studies significantly influenced the reduction in AHI achieved, whereas the baseline AHI did not show any significant correlation. CONCLUSION: Oral appliance therapy (OAT) can be a reliable treatment modality to treat OSA, and performing a separate overnight posttreatment titration study further ensures its effectiveness. Furthermore, OAT can be an effective treatment modality even for moderate-to-severe OSA with posttreatment titration.

Effect of addition of chin strap on PAP compliance, nightly duration of use, and other factors.

STUDY OBJECTIVES: A chinstrap is potentially useful to reduce unintentional air leak by preventing mouth opening during PAP treatment. This study examines whether the addition of a chinstrap to PAP therapy has any effect on adherence, nightly duration of use, air leak, and residual AHI. METHODS: This was a retrospective study performed at an AASM-accredited VAMC sleep center. Clinical sleep data of veterans (n = 124) prescribed PAP therapy for sleep apnea was evaluated, and the effect of chinstrap use vs non-use on the above parameters was assessed. RESULTS: Chinstrap users had significantly greater PAP adherence, longer nightly duration of PAP use, lower residual AHI and lower leak compared to chinstrap non-users at first follow up visit. CONCLUSIONS: The addition of a chin strap to PAP therapy is a simple and inexpensive method of increasing PAP adherence.