Understanding the Sleep Apnea/Insomnia Interaction

NCT01824472 | Completed Results DMC

• 2 other identifiers: 814153R34HL109462
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

CPAP+CC

ACTIVE COMPARATOR

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

Device: CPAP; Behavioral: CC

sham CPAP+CC

SHAM COMPARATOR

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

Device: sham CPAP; Behavioral: CC

CPAP+CBT

ACTIVE COMPARATOR

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

Device: CPAP; Behavioral: CBT

Interventions

CPAP DEVICE

Treatment for sleep apnea

Also known as: Continuous positive airway pressure therapy

CPAP+CBT; CPAP+CC

CBT BEHAVIORAL

Treatment for insomnia

Also known as: Cognitive-Behavioral Therapy for Insomnia

CPAP+CBT

sham CPAP DEVICE

Placebo for sleep apnea

Also known as: Sham (placebo) continuous positive airway pressure

sham CPAP+CC

CC BEHAVIORAL

Placebo (sham) for insomnia

Also known as: Contact control

CPAP+CC; sham CPAP+CC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sleep Apnea
• Insomnia
• Age \>18

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders

Interventions

Cognitive Behavioral Therapy; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Nalaka Gooneratne
• Organization: University of Pennsylvania

ngoonera@upenn.edu

215 573 2048

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 4, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: August 5, 2020
• Results First Posted: August 5, 2020

Record last verified: 2020-07

Locations

US (1)