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Understanding the Sleep Apnea/Insomnia Interaction

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nalaka Gooneratne, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01824472
First received: April 1, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  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: June 2016 (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
Genders Eligible for Study:   Both
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

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
  More Information

No publications provided

Responsible Party: Nalaka Gooneratne, Associate Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01824472     History of Changes
Other Study ID Numbers: 814153, R34HL109462
Study First Received: April 1, 2013
Last Updated: April 1, 2013
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
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 23, 2014