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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04473534

Enrollment

Registered

2020-07-16

Start date

2021-03-10

Completion date

2022-03-30

Last updated

2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia, Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea, Insomnia, Web based CBT-I, CPAP treatment, Rehabilitation

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.

Interventions

BEHAVIORALweb based cognitive-behavioral therapy

one web session of psycho-education about sleep

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Insomnia Severity	Baseline	Assessed by Insomnia Severity Index

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026