Understanding the Sleep Apnea/Insomnia Interaction
This study is currently recruiting participants.
(see Contacts and Locations)
Verified August 2016 by University of Pennsylvania
Sponsor:
University of Pennsylvania
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01824472
First received: April 1, 2013
Last updated: August 17, 2016
Last verified: August 2016
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Purpose
Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.
| Condition | Intervention | Phase |
|---|---|---|
|
Sleep Apnea Syndromes Sleep Initiation and Maintenance Disorders |
Device: CPAP Behavioral: CBT Device: sham CPAP Behavioral: CC |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial |
Resource links provided by NLM:
Further study details as provided by University of Pennsylvania:
Primary Outcome Measures:
- Insomnia Severity Index Score [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 108 |
| Study Start Date: | March 2013 |
| Estimated Primary Completion Date: | March 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824472
Please refer to this study by its ClinicalTrials.gov identifier: NCT01824472
Contacts
| Contact: Nalaka Gooneratne, MD | 215 349 5948 | ngoonera@mail.med.upenn.edu |
Locations
| United States, Pennsylvania | |
| University of Pennsylvania Health System | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
More Information
| Responsible Party: | University of Pennsylvania |
| ClinicalTrials.gov Identifier: | NCT01824472 History of Changes |
| Other Study ID Numbers: | 814153 R34HL109462 |
| Study First Received: | April 1, 2013 |
| Last Updated: | August 17, 2016 |
| Health Authority: | United States: University of Pennsylvania IRB#3 United States: University of Pennsylvania Office of Human Research United States: University of Pennsyvlania Clinical and Translational Research Center |
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 |
ClinicalTrials.gov processed this record on September 23, 2016