# Stepped-care management of insomnia co-occurring with sleep apnea

> **NIH NIH R01** · NATIONAL JEWISH HEALTH · 2020 · $678,486

## Abstract

PROJECT SUMMARY/ABSTRACT
 Obstructive sleep apnea (OSA) and chronic insomnia are prevalent, debilitating, and challenging to treat,
but their all too common co-occurrence amplifies morbidity and complicates the management of affected
patients. Unfortunately, previous research provides limited guidance as to what constitutes the best and most
practical management approach for this comorbid patient group. Various medications have FDA approval for
insomnia management, but most have not been tested among comorbid OSA/insomnia patients. Moreover,
many of these agents suppress respiratory drive making apnea symptoms worse, whereas others result in
residual sedation, an unwanted side effect for the already sleepy OSA patient. Some promising preliminary data
suggest that cognitive-behavioral insomnia therapy (CBT) may be a safe and effective adjunct to standard OSA
therapies for comorbid OSA/insomnia. However, studies reporting these findings have included small patient
samples, lacked both control groups and adequate follow-up periods, and failed to address how this promising
therapy can be made more broadly accessible given the currently limited number of providers capable of
delivering it. This dual-site randomized clinical trial will move the field forward by addressing the limitations of
this previous studies. Specifically this project 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 OCBT
improves short-term outcomes of comorbid OSA/insomnia; and (2) providing a higher intensity 2nd-stage CBT to
patients who show sub-optimal short-term outcomes with OCBT+PAP improves short and longer-term outcomes.
The 384 PAP-treated comorbid OSA\insomnia patients enrolled will complete baseline assessment with sets of
syndrome-specific measures as well as global measures of sleep/wake functioning. They then will be randomly
assigned to a treatment consisting of the UC alone or PAP +OCBT. After 8 weeks they will be reassessed with
all measures taken at baseline. Patients reaching remission status (insomnia severity index score < 10 + Quebec
Sleep Questionnaire mean item score > 5) will be offered no additional insomnia intervention but will continue
PAP and complete study outcome measures again after an additional 8-weeks and again 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 a continued, expanded engagement with the OCBT or a switch to a therapist-
directed CBT (TCBT). Those receiving the 2nd-stage intervention as well as the UC group will be reassessed
after another 8 weeks and then again at 3- and 6-month follow-up time points. Results should provide much new
information that greatly enhances our knowledge about how to effectively treat comorbid OSA/insomnia patients
and about the role of OCBT intervention in the short- and longer...

## Key facts

- **NIH application ID:** 9969403
- **Project number:** 5R01HL130559-05
- **Recipient organization:** NATIONAL JEWISH HEALTH
- **Principal Investigator:** JACK D EDINGER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $678,486
- **Award type:** 5
- **Project period:** 2016-09-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9969403

## Citation

> US National Institutes of Health, RePORTER application 9969403, Stepped-care management of insomnia co-occurring with sleep apnea (5R01HL130559-05). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9969403. Licensed CC0.

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