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Understanding the Sleep Apnea/Insomnia Interaction

This study has been completed.
Sponsor:
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: May 3, 2017
Last verified: May 2017
  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
Sleep Apnea Syndromes Sleep Initiation and Maintenance Disorders Device: CPAP Behavioral: CBT Device: sham CPAP Behavioral: CC

Study Type: Interventional
Study Design: 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

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 ]

Enrollment: 45
Actual Study Start Date: March 2013
Study Completion Date: March 2017
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)
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
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

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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01824472     History of Changes
Other Study ID Numbers: 814153
R34HL109462 ( U.S. NIH Grant/Contract )
Study First Received: April 1, 2013
Last Updated: May 3, 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

ClinicalTrials.gov processed this record on August 23, 2017