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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 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 Design
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Insomnia Severity Index Score [ Time Frame: Day 42 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Sleep Apnea
  2. Insomnia
  3. Age >18

Exclusion Criteria:

  1. Sedative/psychoactive drug use recently
  2. Other clinically significant sleep disorders
  3. Previous treatment for OSA
  4. Requires oxygen or bilevel PAP therapy
  5. Clinically unstable medical condition
  6. Recent shift work
  7. Significant alcohol use
  8. Other clinically significant causes of insomnia
  9. Illicit drug use
  10. Prescription stimulants
  11. Safety restrictions
  12. Unable to treat sleep apnea with positive airway pressure therapy
  13. Communication barriers
  14. Cognitive impairment
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
United States, Pennsylvania
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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