NCT04473534

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

March 10, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

September 29, 2023

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

July 10, 2020

Last Update Submit

September 28, 2023

Conditions

Obstructive Sleep ApneaInsomnia

Keywords

Obstructive sleep apneaInsomniaWeb based CBT-ICPAP treatmentRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Insomnia Severity

    Assessed by Insomnia Severity Index

    Baseline

  • Insomnia Severity

    Assessed by Insomnia Severity Index

    six months of CPAP use

Secondary Outcomes (1)

  • Adherence to CPAP therapy

    six months of use

Study Arms (3)

Arm of CBT-I treatment

EXPERIMENTAL

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

Arm of psycho-education session

EXPERIMENTAL

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

Arm of control TAU (Treatment As Usual)

NO INTERVENTION

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.

Interventions

web based cognitive-behavioral therapyBEHAVIORAL

one web session of psycho-education about sleep

Also known as: Arm of psycho-education session
Arm of CBT-I treatmentArm of psycho-education session

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Complex sleep apnea
  • AHI \>35
  • Psychiatric comorbidies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabio Rossato

Veruno, Novara, 28013, Italy

Location

Related Publications (2)

  • 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.

    PMID: 31403168BACKGROUND

  • 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.

    PMID: 31927569BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 16, 2020

Study Start

March 10, 2021

Primary Completion

December 31, 2021

Study Completion

March 30, 2022

Last Updated

September 29, 2023

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)