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

Primary Purpose

Sleep Apnea, Obstructive

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CPAP
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Grenoble Alps University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CPAP treatment

Arm Description

All included OSA patients are going to be treated by CPAP

Outcomes

Primary Outcome Measures

Effect of CPAP on phone usage habits indices
Changes in indices of phone usage habits

Secondary Outcome Measures

Time course evolution of phone usage habits indices and evolution of sleepiness
Assessment of sleepiness by ESS
Time course evolution of phone usage habits indices and evolution of depression
Assessment of depression by Pichot scale
Time course evolution of phone usage habits indices and evolution of quality of life
Assessment of quality of life by SF-36
Time course evolution of phone usage habits indices and evolution of locomotion
patterns of locomotion objectively measured by a gait platform
CPAP adherence
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
Care access questionnaire developed by ODENORE and National French insurance
Effect of food habit with CPAP treatment
Changes in food frequence questionnaire

Full Information

First Posted
March 28, 2018
Last Updated
May 17, 2022
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT03537066
Brief Title
CALLSAS Study: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits
Acronym
CALLSAS
Official Title
Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits: the Callsas Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
inability to include subjects on schedule
Study Start Date
April 10, 2018 (Actual)
Primary Completion Date
October 10, 2018 (Actual)
Study Completion Date
June 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP treatment
Arm Type
Other
Arm Description
All included OSA patients are going to be treated by CPAP
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
All patients included will be treated by CPAP
Primary Outcome Measure Information:
Title
Effect of CPAP on phone usage habits indices
Description
Changes in indices of phone usage habits
Time Frame
from 6 months before CPAP treatment until 6 months after CPAP treatment initiation
Secondary Outcome Measure Information:
Title
Time course evolution of phone usage habits indices and evolution of sleepiness
Description
Assessment of sleepiness by ESS
Time Frame
from CPAP initiation until 6 months after CPAP treatment initiation
Title
Time course evolution of phone usage habits indices and evolution of depression
Description
Assessment of depression by Pichot scale
Time Frame
from CPAP initiation until 6 months after CPAP treatment initiation
Title
Time course evolution of phone usage habits indices and evolution of quality of life
Description
Assessment of quality of life by SF-36
Time Frame
from CPAP initiation until 6 months after CPAP treatment initiation
Title
Time course evolution of phone usage habits indices and evolution of locomotion
Description
patterns of locomotion objectively measured by a gait platform
Time Frame
from CPAP initiation until 6 months after CPAP treatment initiation
Title
CPAP adherence
Description
Time course evolution of CPAP adherence assessed by telemonitoring versus time course evolution of phone usage habits
Time Frame
from CPAP initiation until 6 months after CPAP treatment initiation
Title
Access to care as a predictor of CPAP adherence
Description
Care access questionnaire developed by ODENORE and National French insurance
Time Frame
from CPAP initiation until 6 months after CPAP treatment initiation
Title
Effect of food habit with CPAP treatment
Description
Changes in food frequence questionnaire
Time Frame
At CPAP initiation and at 6 months after CPAP treatment initiation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis PEPIN
Organizational Affiliation
CHU Grenoble Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grenoble Alps University Hospital
City
Grenoble
State/Province
Rhône Alpes
ZIP/Postal Code
38000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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