Understanding the Sleep Apnea/Insomnia Interaction

University of Pennsylvania

Status: Completed

Conditions: Sleep Initiation and Maintenance Disorders; Sleep Apnea Syndromes

Treatments: Behavioral: CBT; Device: sham CPAP; Behavioral: CC; Device: CPAP

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01824472

R34HL109462 (U.S. NIH Grant/Contract)

814153

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

CPAP+CC

Active Comparator group

Description:

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

Treatment:

Device: CPAP

Behavioral: CC

sham CPAP+CC

Sham Comparator group

Description:

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

Treatment:

Behavioral: CC

Device: sham CPAP

CPAP+CBT

Active Comparator group

Description:

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

Treatment:

Device: CPAP

Behavioral: CBT