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Understanding the Sleep Apnea/Insomnia Interaction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01824472
First Posted: April 4, 2013
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania
April 1, 2013
April 4, 2013
May 8, 2017
March 2013
March 2017   (Final data collection date for primary outcome measure)
Insomnia Severity Index Score [ Time Frame: Day 42 ]
Same as current
Complete list of historical versions of study NCT01824472 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Understanding the Sleep Apnea/Insomnia Interaction
Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
  • Sleep Apnea Syndromes
  • Sleep Initiation and Maintenance Disorders
  • 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
  • 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+CC
    CPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
    Interventions:
    • Device: CPAP
    • Behavioral: CC
  • 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)
    Interventions:
    • Device: sham CPAP
    • Behavioral: CC
  • Active Comparator: CPAP+CBT
    CPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia
    Interventions:
    • Device: CPAP
    • Behavioral: CBT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
March 2017
March 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01824472
814153
R34HL109462 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Not Provided
University of Pennsylvania
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP