Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2021-03-10
2022-03-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
web based cognitive-behavioral therapy
one web session of psycho-education about sleep
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
web based cognitive-behavioral therapy
one web session of psycho-education about sleep
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.
No interventions assigned to this group
Interventions
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web based cognitive-behavioral therapy
one web session of psycho-education about sleep
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Apnea-Hypopnea Index (AHI) ≥5
Exclusion Criteria
* AHI \>35
* Psychiatric comorbidies
18 Years
80 Years
ALL
No
Sponsors
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Istituti Clinici Scientifici Maugeri SpA
OTHER
Responsible Party
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Locations
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Fabio Rossato
Veruno, Novara, Italy
Countries
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References
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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.
Other Identifiers
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2361
Identifier Type: -
Identifier Source: org_study_id
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