Web Based CBT-I in Patients With OSA and Insomnia

Web Based Cognitive-behavioral Therapy in Patients With Obstructive Sleep Apnoea Syndrome and Insomnia: a Randomized Clinical Trial

Obstructive sleep apnea (OSA) and insomnia often occur in the same patient. Recent studies have demonstrated the efficacy of cognitive behavioral therapy (CBT-I) in patients with insomnia and OSA. Our aim is to verify the efficacy of web based CBT-I in patients with OSA and insomnia and the effect of web based CBT-I on the acceptance and adherence to CPAP (Continuous Positive Airway Pressure) therapy.

Study Overview

• Status: Withdrawn
• Conditions: Insomnia; Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: web based cognitive-behavioral therapy

Detailed Description

Obstructive sleep apnea is one of the most common sleep disorders with high prevalence in males sex, is often associated with insomnia. The presence of both sleep disorders generates a vicious circle that exacerbates the clinical picture, makes difficult to accept and adhere to CPAP therapy and increase cardiovascular risk. CBT-I is considered the best treatment for insomnia and recent research has demonstrated the efficacy of CBT-I also when insomnia is associated with OSA. After six month of treatment we will test the efficacy of web-based CBT-I in patients with OSA and insomnia in comparison to one session of psycho education on sleep, OSA, insomnia, the interaction among them and the influence on CPAP adherence.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Novara
    • Veruno, Novara, Italy, 28013
      • Fabio Rossato

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18
• Apnea-Hypopnea Index (AHI) ≥5

Exclusion Criteria:

• Complex sleep apnea
• AHI >35
• Psychiatric comorbidies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm of CBT-I treatment; Web cognitive behavioral therapy was administered before starting CPAP use by a psychologist expert in behavioral sleep medicine and expert in CBT-I. CBT-I was administered according to the same model and standard visual approach in patients with insomnia. Five sessions are scheduled: sleep psycho-education, sleep restriction, stimulus control, sleep hygiene and challenging beliefs and perception of sleep.	Behavioral: web based cognitive-behavioral therapy; one web session of psycho-education about sleep; Other Names: Arm of psycho-education session
Experimental: Arm of psycho-education session; Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use	Behavioral: web based cognitive-behavioral therapy; one web session of psycho-education about sleep; Other Names: Arm of psycho-education session
No Intervention: Arm of control TAU (Treatment As Usual); The control group will receive TAU. Each patient will start to use CPAP after the diagnosis according to AASM (American Academy of Sleep Medicine) guideline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity	Assessed by Insomnia Severity Index	Baseline
Insomnia Severity	Assessed by Insomnia Severity Index	six months of CPAP use

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to CPAP therapy	Hours of CPAP use during sleep with download of data	six months of use

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA

Publications and helpful links

General Publications

• Sweetman A, Lack L, Catcheside PG, Antic NA, Smith S, Chai-Coetzer CL, Douglas J, O'grady A, Dunn N, Robinson J, Paul D, Williamson P, McEvoy RD. Cognitive and behavioral therapy for insomnia increases the use of continuous positive airway pressure therapy in obstructive sleep apnea participants with comorbid insomnia: a randomized clinical trial. Sleep. 2019 Dec 24;42(12):zsz178. doi: 10.1093/sleep/zsz178.
• Sweetman A, McEvoy RD, Smith S, Catcheside PG, Antic NA, Chai-Coetzer CL, Douglas J, O'Grady A, Dunn N, Robinson J, Paul D, Williamson P, Lack L. The effect of cognitive and behavioral therapy for insomnia on week-to-week changes in sleepiness and sleep parameters in patients with comorbid insomnia and sleep apnea: a randomized controlled trial. Sleep. 2020 Jul 13;43(7):zsaa002. doi: 10.1093/sleep/zsaa002.

Study record dates

Study Major Dates

• Study Start (Estimated): March 10, 2021
• Primary Completion (Estimated): December 31, 2021
• Study Completion (Estimated): March 30, 2022

Study Registration Dates

• First Submitted: July 10, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2023
• Last Update Submitted That Met QC Criteria: September 28, 2023
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Obstructive sleep apnea; Insomnia; CPAP treatment; Web based CBT-I
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders; Apnea
• Other Study ID Numbers: 2361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No