Web Based CBT-I in Patients With OSA and Insomnia

I

Istituti Clinici Scientifici Maugeri SpA

Status

Withdrawn

Conditions

Insomnia
Obstructive Sleep Apnea

Treatments

Behavioral: web based cognitive-behavioral therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04473534
2361

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Complex sleep apnea
  • AHI >35
  • Psychiatric comorbidies

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Arm of CBT-I treatment
Experimental group
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.
Treatment:
Behavioral: web based cognitive-behavioral therapy
Arm of psycho-education session
Experimental group
Description:
Single session of psycho-education about sleep, OSA, insomnia and interaction among them will be administered by web before beginning CPAP use
Treatment:
Behavioral: web based cognitive-behavioral therapy
Arm of control TAU (Treatment As Usual)
No Intervention group
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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