Completed

Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial

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What is being tested

CPAP

+ CC

+ sham CPAP

DeviceBehavioral
Who is being recruted

Apnea+7

+ Mental Disorders

+ Nervous System Diseases

Over 18 Years
+17 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: March 2013
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: August 5, 2020
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01824472
Principal SponsorUniversity of Pennsylvania
Last updated: August 5, 2020
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ApneaMental DisordersNervous System DiseasesRespiration DisordersRespiratory Tract DiseasesSleep Wake DisordersSleep Disorders, IntrinsicDyssomniasSleep Initiation and Maintenance DisordersSleep Apnea Syndromes

Criteria

3 inclusion criteria required to participate
Age > 18
Insomnia
Sleep Apnea
14 exclusion criteria prevent from participating
Clinically unstable medical condition
Cognitive impairment
Communication barriers
Illicit drug use
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia)

Group II

Sham
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)

Group III

Active Comparator
CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Pennsylvania Health System

Philadelphia, United StatesOpen University of Pennsylvania Health System in Google Maps
CompletedOne Study Center