Clinical trial NCT03537066: CALLSAS Study: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits
Official title: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits: the Callsas Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-05-25
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Continuous positive airway pressure (CPAP) treatment improves sleepiness, depression and social activities in patients with obstructive sleep apnea (OSA). This evolution can be captured from changes in phone usage habits coupled with a mobile-based services. The aim of this study is to assess the impact of CPAP treatment on phone usage habits in OSA patients.

Detailed description: Callsas is a prospective study embarking newly diagnosed obstructive sleep apnea patients initiated to CPAP treatment.

The primary objective is to analyze the modifications in phone usage habits before and after CPAP treatment.

Secondary objectives:

* Correlation between changes in phone usage habits and evolution of sleepiness
* Correlation between changes in phone usage habits and evolution of depression scale
* Correlation between changes in phone usage habits and evolution of quality of life
* Correlation between changes in physical activity measured by phones and evolution of physical activity objectively measured by actigraphy and gait platform
* Correlation between phone usage habits and CPAP adherence

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed OSA patients initiated on CPAP
* Follow-up at home by AGIR à dom
* Customers of Orange (or Sosh) for mobile and/or fixed-line telephony for at least 6 months
* Patient who signed a written consent to participate in the study
* Patient affiliated to social security

Exclusion Criteria:

* Pregnant women
* Patients with disease not allowing to realize functional and locomotion tests
* Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship)
* Patient who, in the judgment of the investigator, may not be cooperative or respectful of the obligations inherent to participation in the study

Primary outcomes:
measure: Effect of CPAP on phone usage habits indices
timeFrame: from 6 months before CPAP treatment until 6 months after CPAP treatment initiation
Secondary outcomes:
measure: Time course evolution of phone usage habits indices and evolution of sleepiness
timeFrame: from CPAP initiation until 6 months after CPAP treatment initiation
measure: Time course evolution of phone usage habits indices and evolution of depression
timeFrame: from CPAP initiation until 6 months after CPAP treatment initiation
measure: Time course evolution of phone usage habits indices and evolution of quality of life
timeFrame: from CPAP initiation until 6 months after CPAP treatment initiation
measure: Time course evolution of phone usage habits indices and evolution of locomotion
timeFrame: from CPAP initiation until 6 months after CPAP treatment initiation
measure: CPAP adherence
timeFrame: from CPAP initiation until 6 months after CPAP treatment initiation
measure: Access to care as a predictor of CPAP adherence
timeFrame: from CPAP initiation until 6 months after CPAP treatment initiation
measure: Effect of food habit with CPAP treatment
timeFrame: At CPAP initiation and at 6 months after CPAP treatment initiation
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Grenoble Alps University Hospital
state: Rhône Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Jean-Louis PEPIN
role: PRINCIPAL_INVESTIGATOR
References: