Understanding the Sleep Apnea/Insomnia Interaction
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ClinicalTrials.gov Identifier: NCT01824472 |
Recruitment Status
:
Completed
First Posted
: April 4, 2013
Last Update Posted
: May 8, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sleep Apnea Syndromes Sleep Initiation and Maintenance Disorders | Device: CPAP Behavioral: CBT Device: sham CPAP Behavioral: CC | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial |
Actual Study Start Date : | March 2013 |
Actual Primary Completion Date : | March 2017 |
Actual Study Completion Date : | March 2017 |

Arm | Intervention/treatment |
---|---|
Active Comparator: CPAP+CC
CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
|
Device: CPAP
Treatment for sleep apnea
Other Name: Continuous positive airway pressure therapy
Behavioral: CC
Placebo (sham) for insomnia
Other Name: Contact control
|
Sham Comparator: sham CPAP+CC
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
|
Device: sham CPAP
Placebo for sleep apnea
Other Name: Sham (placebo) continuous positive airway pressure
Behavioral: CC
Placebo (sham) for insomnia
Other Name: Contact control
|
Active Comparator: CPAP+CBT
CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
|
Device: CPAP
Treatment for sleep apnea
Other Name: Continuous positive airway pressure therapy
Behavioral: CBT
Treatment for insomnia
Other Name: Cognitive-Behavioral Therapy for Insomnia
|
- Insomnia Severity Index Score [ Time Frame: Day 42 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Sleep Apnea
- Insomnia
- Age >18
Exclusion Criteria:
- Sedative/psychoactive drug use recently
- Other clinically significant sleep disorders
- Previous treatment for OSA
- Requires oxygen or bilevel PAP therapy
- Clinically unstable medical condition
- Recent shift work
- Significant alcohol use
- Other clinically significant causes of insomnia
- Illicit drug use
- Prescription stimulants
- Safety restrictions
- Unable to treat sleep apnea with positive airway pressure therapy
- Communication barriers
- Cognitive impairment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01824472
United States, Pennsylvania | |
University of Pennsylvania Health System | |
Philadelphia, Pennsylvania, United States, 19104 |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01824472 History of Changes |
Other Study ID Numbers: |
814153 R34HL109462 ( U.S. NIH Grant/Contract ) |
First Posted: | April 4, 2013 Key Record Dates |
Last Update Posted: | May 8, 2017 |
Last Verified: | May 2017 |
Additional relevant MeSH terms:
Apnea Sleep Apnea Syndromes Sleep Initiation and Maintenance Disorders Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders |