Web Based CBT-I in Patients With OSA and Insomnia

Study Overview
=================
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.

Official Title
-----------------
Web Based Cognitive-behavioral Therapy in Patients With Obstructive Sleep Apnoea Syndrome and Insomnia: a Randomized Clinical Trial

Conditions
-----------------
Obstructive Sleep Apnea, Insomnia

Intervention / Treatment
-----------------
* Behavioral: web based cognitive-behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 Apnea-Hypopnea Index (AHI) ≥5 Exclusion Criteria: Complex sleep apnea AHI >35 Psychiatric comorbidies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm of CBT-I treatment<br>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<br>* one web session of psycho-education about sleep<br>* Other names: Arm of psycho-education session;|
| Experimental: Arm of psycho-education session<br>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<br>* one web session of psycho-education about sleep<br>* Other names: Arm of psycho-education session;|
| No Intervention: Arm of control TAU (Treatment As Usual)<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia Severity | Assessed by Insomnia Severity Index | Baseline | 
| Insomnia Severity | Assessed by Insomnia Severity Index | six months of CPAP use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to CPAP therapy | Hours of CPAP use during sleep with download of data | six months of use | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive sleep apnea, Insomnia, Web based CBT-I, CPAP treatment, Rehabilitation