Clinical Trials Logo

Clinical Trial Summary

This two-site randomized clinical trial will investigate and compare three treatments for insomnia in patients who have been diagnosed with and treated for sleep apnea: online cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT), and standard clinical care. 384 patients will be recruited and will attend up to 15 visits over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment follow-up visits. Visits will involve completion of questionnaires, meeting with therapists, and a physical exam.


Clinical Trial Description

This dual-site randomized clinical trial will use a "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 online Cognitive Behavioral Therapy improves short-term outcomes of comorbid obstructive sleep apnea(OSA)/insomnia; and (2) providing a higher intensity 2nd-stage cognitive behavioral therapy (CBT) to patients who show sub-optimal short-term outcomes with OCBT+PAP improves short and longer-term outcomes. After completing baseline assessment, the 384 comorbid OSA\insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT (n=288) or UC (usual care PAP + sleep hygiene education; n=96). Insomnia and OSA will be reassessed after 8 weeks. OCBT recipients who meet "remission" criteria will continue PAP but be offered no additional insomnia intervention and will complete study outcome measures again after an additional 8-weeks and at 3 and 6 month follow-ups. OCBT recipients classified as "unremitted" after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, expanded engagement in OCBT or a switch to therapist-directed CBT (TCBT). 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03109210
Study type Interventional
Source National Jewish Health
Contact
Status Active, not recruiting
Phase N/A
Start date April 15, 2017
Completion date June 30, 2024

See also
  Status Clinical Trial Phase
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT04912635 - Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo N/A
Not yet recruiting NCT05939934 - Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal N/A
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Terminated NCT02269774 - Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea N/A
Completed NCT02088723 - Testing the Elevation as Sleep Apnea Treatment N/A
Completed NCT02261857 - 3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea Early Phase 1
Completed NCT01181570 - Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea Phase 4
Completed NCT01943708 - Novel Auto-continuous Positive Airway Pressure (CPAP) Validation Phase 3
Completed NCT00273754 - The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). Phase 2
Recruiting NCT02166879 - Undetected Sleep Apnea in the Postanesthesia Acute Care Unit (PACU)
Recruiting NCT04963192 - Integrated Management of Chronic Respiratory Diseases N/A
Completed NCT05056766 - How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
Completed NCT04846400 - Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia N/A
Recruiting NCT04314492 - Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults N/A
Completed NCT05175287 - OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
Active, not recruiting NCT03431038 - Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH N/A
Enrolling by invitation NCT03075787 - Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea N/A
Completed NCT03300037 - HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor N/A
Recruiting NCT06097949 - AcuPebble to Remotely Monitor Patients With OSA on CPAP Therapy