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

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

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.

Study Overview

• Status: Terminated
• Conditions: Sleep Apnea, Obstructive
• Intervention / Treatment: Device: CPAP

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 Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône Alpes
    • Grenoble, Rhône Alpes, France, 38000
      • Grenoble Alps University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of CPAP on phone usage habits indices	Changes in indices of phone usage habits	from 6 months before CPAP treatment until 6 months after CPAP treatment initiation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: Jean-Louis PEPIN, CHU Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2018
• Primary Completion (Actual): October 10, 2018
• Study Completion (Actual): June 15, 2021

Study Registration Dates

• First Submitted: March 28, 2018
• First Submitted That Met QC Criteria: May 14, 2018
• First Posted (Actual): May 25, 2018

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2017-A02540-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No