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OpenTrials
Completed

NCT Number: NCT01824472

Understanding the Sleep Apnea/Insomnia Interaction

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.

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Key information

Conditions

Sleep Apnea Syndromes Apnea Dyssomnias Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Sleep Apnea
  • Insomnia
  • Age >18

Exclusion criteria

  • Sedative/psychoactive drug use recently
  • Other clinically significant sleep disorders
  • Previous treatment for obstructive sleep apnea (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

Treatment and study plan

CPAP

Device

Treatment for sleep apnea

Other names: Continuous positive airway pressure therapy

CBT

Behavioral

Treatment for insomnia

Other names: Cognitive-Behavioral Therapy for Insomnia

Sham CPAP

Device

Placebo for sleep apnea

Other names: Sham (placebo) continuous positive airway pressure

CC

Behavioral

Placebo (sham) for insomnia

Other names: Contact control

Primary outcomes

  1. Insomnia Severity Index Score

    Time frame: Between Baseline and Day 42.

    Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2013
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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