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| Name | Class |
|---|---|
| Stanford University | OTHER |
| National Jewish Health | OTHER |
| Rush University Medical Center | OTHER |
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The overall goal of this project is to determine the efficacy of a multidisciplinary treatment model for patients with Obstructive Sleep Apnea (OSA) and comorbid Insomnia.
Specific Aim 1: To determine the efficacy of a treatment model combining Cognitive Behavioral Therapy (CBT) and Continued Positive Airway Pressure(CPAP) for individuals with OSA and comorbid insomnia.
Specific Aim 2: To determine if there are relative benefits in the sequence of treatment initiation.
Specific Aim 3: To examine the mechanisms between insomnia symptoms and CPAP adherence.
OSA is a sleep-related breathing disorder that is growing in prevalence and is associated with negative cardiovascular consequences and adverse events from excessive daytime sleepiness. Insomnia is a frequently co-occurring sleep disorder that adds significant morbidity and is a potential barrier to adherence of OSA treatment. It is currently unknown if direct treatment of insomnia will enhance outcomes of OSA treatment. The investigators at the Rush Sleep Disorders Center have developed an approach that combines CBT for insomnia delivered by a psychologist with CPAP therapy managed by a physician. Building upon preliminary data collected in the clinic, the investigators seek to test the efficacy and mechanisms of this multidisciplinary model against the standard practice of treating OSA using CPAP alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Model A | Active Comparator | Model A consists of a 4 session CBT-I in phase I and CPAP for OSA in Phase II. |
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| Model B | Active Comparator | Model B consists of 4 weeks of monitoring using sleep diaries in Phase I. Phase II consists of concurrent initiation of CBT-I and CPAP for OSA. |
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| Model C | Other | Model C consists of 4 weeks of monitoring with sleep diaries in Phase I. Phase II consists of CPAP for OSA. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CBT-I | Behavioral | Cognitive Behavior Therapy for Insomnia (CBT-I) consists of 4 weekly sessions delivered individually. The focus of these sessions is on modifying behaviors and cognitions related to sleep and insomnia. |
| Measure | Description | Time Frame |
|---|---|---|
| CPAP adherence | CPAP adherence is defined as % nights used and hrs per night and % of "good users" (≥ 4 hours on ≥ 70% of nights) | 90 days after CPAP initiation |
| Pittsburgh Sleep Quality Index (PSQI) | Improvements in sleep quality is defined as change of PSQI score from baseline to 90 days after CPAP initiation. | 90 days after CPAP initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Polysomnography (PSG) | Improvement in PSG sleep efficiency at the end of Phase I | End of phase 1 (1 month after baseline assessment) |
| Insomnia Severity Index (ISI) | Improvement in ISI from baseline to 90 days after CPAP initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Severity Scale (FSS) | Improvement in FSS from baseline to 90 days after CPAP initiation (End of Phase II). | 90 days after CPAP initiation |
| Epworth Sleepiness Scale (ESS) | Improvement in ESS from baseline to 90 days after CPAP initiation. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Ong, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Circadian and Sleep Medicine, Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37148183 | Derived | Turner AD, Ong JC, Jones AL, Tu A, Salanitro M, Crawford MR. Neurocognitive functioning in comorbid insomnia and sleep apnea patients is better after positive airway pressure therapy, but worse after cognitive behavioral therapy for insomnia: exploratory analysis of cognitive outcomes from the Multidisciplinary Approach to the Treatment of Insomnia and Comorbid Sleep Apnea study. Sleep. 2023 Aug 14;46(8):zsad128. doi: 10.1093/sleep/zsad128. | |
| 34648425 | Derived |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| CPAP | Procedure | CPAP is an FDA-approved medical device used to treat obstructive sleep apnea. This device consists of a mask, hose, and machine that blows continuous air which maintains a consistent pressure of airflow preventing the upper airway from collapsing during sleep. |
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| 90 days after CPAP initiation |
| Functional Outcomes of Sleep Questionnaire (FOSQ) | Improvement in FOSQ from baseline to 90 days after CPAP initiation | 90 days after CPAP initiation |
| Actigraphy | Improvement in sleep as measured by actigraphy from baseline to 90 days after CPAP initiation. | 90 days after CPAP initiation |
| 90 days after CPAP initiation |
| Tu AY, Crawford MR, Dawson SC, Fogg LF, Turner AD, Wyatt JK, Crisostomo MI, Chhangani BS, Kushida CA, Edinger JD, Abbott SM, Malkani RG, Attarian HP, Zee PC, Ong JC. A randomized controlled trial of cognitive behavioral therapy for insomnia and PAP for obstructive sleep apnea and comorbid insomnia: effects on nocturnal sleep and daytime performance. J Clin Sleep Med. 2022 Mar 1;18(3):789-800. doi: 10.5664/jcsm.9696. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012138 |
| Respiratory Therapy |