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Web Based CBT-I in Patients With OSA and Insomnia

Primary Purpose

Obstructive Sleep Apnea, Insomnia

Status
Withdrawn
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
web based cognitive-behavioral therapy
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive sleep apnea, Insomnia, Web based CBT-I, CPAP treatment, Rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Complex sleep apnea
  • AHI >35
  • Psychiatric comorbidies

Sites / Locations

  • Fabio Rossato

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Arm of CBT-I treatment

Arm of psycho-education session

Arm of control TAU (Treatment As Usual)

Arm Description

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.

Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use

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.

Outcomes

Primary Outcome Measures

Insomnia Severity
Assessed by Insomnia Severity Index
Insomnia Severity
Assessed by Insomnia Severity Index

Secondary Outcome Measures

Adherence to CPAP therapy
Hours of CPAP use during sleep with download of data

Full Information

First Posted
July 10, 2020
Last Updated
September 28, 2023
Sponsor
Istituti Clinici Scientifici Maugeri SpA
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1. Study Identification

Unique Protocol Identification Number
NCT04473534
Brief Title
Web Based CBT-I in Patients With OSA and Insomnia
Official Title
Web Based Cognitive-behavioral Therapy in Patients With Obstructive Sleep Apnoea Syndrome and Insomnia: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study halted prematurely becauase of organisational problems.
Study Start Date
March 10, 2021 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituti Clinici Scientifici Maugeri SpA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Insomnia
Keywords
Obstructive sleep apnea, Insomnia, Web based CBT-I, CPAP treatment, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm of CBT-I treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm of psycho-education session
Arm Type
Experimental
Arm Description
Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use
Arm Title
Arm of control TAU (Treatment As Usual)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
web based cognitive-behavioral therapy
Other Intervention Name(s)
Arm of psycho-education session
Intervention Description
one web session of psycho-education about sleep
Primary Outcome Measure Information:
Title
Insomnia Severity
Description
Assessed by Insomnia Severity Index
Time Frame
Baseline
Title
Insomnia Severity
Description
Assessed by Insomnia Severity Index
Time Frame
six months of CPAP use
Secondary Outcome Measure Information:
Title
Adherence to CPAP therapy
Description
Hours of CPAP use during sleep with download of data
Time Frame
six months of use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥18 Apnea-Hypopnea Index (AHI) ≥5 Exclusion Criteria: Complex sleep apnea AHI >35 Psychiatric comorbidies
Facility Information:
Facility Name
Fabio Rossato
City
Veruno
State/Province
Novara
ZIP/Postal Code
28013
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31403168
Citation
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.
Results Reference
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PubMed Identifier
31927569
Citation
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.
Results Reference
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Web Based CBT-I in Patients With OSA and Insomnia

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