Understanding the Sleep Apnea/Insomnia Interaction

Sleep Apnea Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01824472
• Other study ID #: 814153
• Secondary ID: R34HL109462
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: March 2017

Study information

• Verified date: July 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 obstructive sleep apnea (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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• CPAP
Treatment for sleep apnea

Behavioral:
• CBT
Treatment for insomnia

Device:
• sham CPAP
Placebo for sleep apnea

Behavioral:
• CC
Placebo (sham) for insomnia

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insomnia Severity Index Score	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.	Between Baseline and Day 42.