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:

National Heart, Lung, and Blood Institute (NHLBI)

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:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

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:

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

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

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:


Sleep Apnea Syndromes Apnea Dyssomnias Nervous System Diseases	Respiration Disorders Respiratory Tract Diseases Sleep Disorders Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on March 03, 2015

To Top