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

Sleep Apnea, Obstructive Clinical Trial

— CALLSAS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03537066
• Other study ID #: 2017-A02540-53
• Status: Terminated
• Phase: N/A
• Start date: April 10, 2018
• Est. completion date: June 15, 2021

Study information

• Verified date: May 2022
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: June 15, 2021
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
All patients included will be treated by CPAP

Locations

Country	Name	City	State
France	Grenoble Alps University Hospital	Grenoble	Rhône Alpes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Effect of food habit with CPAP treatment	Changes in food frequence questionnaire	At CPAP initiation and at 6 months after CPAP treatment initiation