![]() Regulatory oversight is completed through a yearly review of progress completed by the Institutional Review Board of record. Maintenance of trial data collection system and data entry surveillance Preparation of routine data audit reports Study coordination and data collection in adherence to study protocol.ĭata team (Study statistician, study coordinators): Preparation and submission of regulatory paperwork Site coordinating teams (project manager, study coordinators): Reviewing progress of study and if necessary agreeing changes to the protocol to facilitate the smooth running of the studyĭelivery of cognitive behavioral therapy in accordance with study protocol ![]() Oversight of trial, including supervision of study personnel. Principal investigator and research physician: The sponsor/funding source is not involved in study design, data collection and analysis, interpretation, writing of the report, or decision to submit for publication Louis Velasco, Grants Management Specialist, National Heart Lung and Blood Institute, R01HL130559, -Įlizabeth Devon Eldridge-Smith, Jewish HealthĤ61 Bush St #200, San Francisco, CA 94108, USA Version 2, updated to add remote visit procedures in adaptation to COVID-19 pandemic Trial registrationĬ, NCT03109210, registered on April 12, 2017, prospectively registered.Ĭ, NCT03109210, registered on April 12, 2017 This study will provide new information about optimal interventions for patients with comorbid OSA and insomnia to inform future clinical decision-making processes. Secondary outcomes will include subjective and objective sleep data, including sleep time, sleep efficiency, fatigue ratings, PAP adherence, sleepiness ratings, sleep/wake functioning ratings, and objective daytime alertness. The primary outcome will be insomnia remission. Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and at 3- and 6-month follow-up time points. OCBT-I recipients classified as “unremitted” after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, extended access to OCBT-I or a switch to TCBT-I. OCBT-I recipients who meet “remission” criteria (defined as an Insomnia Severity Index score < 10) will continue PAP but will not be offered any additional insomnia intervention and will complete study outcome measures again after an additional 8 weeks and at 3 and 6 month follow-ups. Insomnia will be reassessed after 8 weeks. After completing baseline assessment, the comorbid OSA/insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT-I or UC (usual care PAP + sleep hygiene education). This dual-site randomized clinical trial will use a Sequential Multiple Assignment Randomized Trial (SMART) design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with OCBT-I improves short-term outcomes of comorbid OSA/insomnia and (2) providing a higher intensity 2nd-stage CBT-I to patients who show sub-optimal short-term outcomes with OCBT-I+PAP improves short and longer-term outcomes. ![]() However, the efficacy of OCBT-I as a 1st-stage therapy within a broader stepped care management strategy for insomnia comorbid with OSA has yet to be tested with comorbid OSA/insomnia patients. Given its putative scalability and apparent efficacy, some have argued OCBT-I should represent a 1st-stage intervention in a broader stepped care model that allocates more intensive and less assessable therapist-delivered CBT-I (TCBT-I) only to those who show an inadequate response to lower intensity OCBT-I. ![]() The emergence of sophisticated online CBT-I (OCBT-I) programs could improve access, showing promising reductions in insomnia severity. However, the dearth of trained providers capable of delivering CBT-I has long served as a pragmatic barrier to the widespread use of this therapy in clinical practice. Some preliminary studies show that when cognitive behavioral insomnia therapy (CBT-I) is combined with standard OSA therapies for these patients, outcomes are improved. Unfortunately, previous research provides limited guidance as to what constitutes the best and most practical management approach for this comorbid patient group. Obstructive sleep apnea (OSA) and insomnia are commonly co-occurring conditions that amplify morbidity and complicates the management of affected patients. ![]()
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