CALLSAS Study: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits

Sponsor

University Hospital, Grenoble (Other)

Overall Status

Terminated

CT.gov ID

NCT03537066

Collaborator

(none)

Enrollment

Location

Arm

38.2

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive	Device: CPAP	N/A

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

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits: the Callsas Study

Actual Study Start Date :

Apr 10, 2018

Actual Primary Completion Date :

Oct 10, 2018

Actual Study Completion Date :

Jun 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: CPAP treatment All included OSA patients are going to be treated by CPAP	Device: CPAP All patients included will be treated by CPAP

Arm

Intervention/Treatment

Other: CPAP treatment

All included OSA patients are going to be treated by CPAP

Device: CPAP

All patients included will be treated by CPAP

Outcome Measures

Primary Outcome Measures

Effect of CPAP on phone usage habits indices [from 6 months before CPAP treatment until 6 months after CPAP treatment initiation]
Changes in indices of phone usage habits

Secondary Outcome Measures

Time course evolution of phone usage habits indices and evolution of sleepiness [from CPAP initiation until 6 months after CPAP treatment initiation]
Assessment of sleepiness by ESS
Time course evolution of phone usage habits indices and evolution of depression [from CPAP initiation until 6 months after CPAP treatment initiation]
Assessment of depression by Pichot scale
Time course evolution of phone usage habits indices and evolution of quality of life [from CPAP initiation until 6 months after CPAP treatment initiation]
Assessment of quality of life by SF-36
Time course evolution of phone usage habits indices and evolution of locomotion [from CPAP initiation until 6 months after CPAP treatment initiation]
patterns of locomotion objectively measured by a gait platform
CPAP adherence [from CPAP initiation until 6 months after CPAP treatment initiation]
Time course evolution of CPAP adherence assessed by telemonitoring versus time course evolution of phone usage habits
Access to care as a predictor of CPAP adherence [from CPAP initiation until 6 months after CPAP treatment initiation]
Care access questionnaire developed by ODENORE and National French insurance
Effect of food habit with CPAP treatment [At CPAP initiation and at 6 months after CPAP treatment initiation]
Changes in food frequence questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Grenoble Alps University Hospital	Grenoble	Rhône Alpes	France	38000

Sponsors and Collaborators

University Hospital, Grenoble

Investigators

Principal Investigator: Jean-Louis PEPIN, CHU Grenoble Alpes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Grenoble

ClinicalTrials.gov Identifier:

NCT03537066

Other Study ID Numbers:

2017-A02540-53

First Posted:

May 25, 2018

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Apnea

Sleep Apnea, Obstructive

Study Results

No Results Posted as of May 24, 2022