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N/A N=45 Randomized Single-blind Treatment

Understanding the Sleep Apnea/Insomnia Interaction

Sleep Apnea Syndromes · Sleep Initiation and Maintenance Disorders

Bottom Line

View on ClinicalTrials.gov: NCT01824472 ↗
Enrolled (actual)
45
Serious AEs
4.4%
Results posted
Aug 2020
Primary outcome: Primary: Insomnia Severity Index Score — -8.2; -7.33; -6.27 score on a scale — p=0.8

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CPAP (Device); CBT (Behavioral); sham CPAP (Device); CC (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
University of Pennsylvania
Primary completion
Mar 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Insomnia Severity Index Score		 -8.2; -7.33; -6.27 0.8

Summary

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.

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01824472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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