CClinicalTrials.gg
TerminatedNCT03537066CALLSASUpdated May 24, 2022

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

An interventional study of CPAP in Sleep Apnea, Obstructive, sponsored by University Hospital, Grenoble. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Treatment

Why this study was terminated
inability to include subjects on schedule
Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Sleep Apnea, Obstructive
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's enrollment of 68 is above the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 816 studies on the registry; 206 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
68 participants (actual)

Study arms

  • Other
    CPAP treatment

    All included OSA patients are going to be treated by CPAP

    Device: CPAP

Interventions

  • DeviceCPAP

    All patients included will be treated by CPAP

06

What researchers measure

Primary outcomes

  1. Effect of CPAP on phone usage habits indices

    Changes in indices of phone usage habits

    Time frame: from 6 months before CPAP treatment until 6 months after CPAP treatment initiation

Secondary outcomes

  1. Time course evolution of phone usage habits indices and evolution of sleepiness

    Assessment of sleepiness by ESS

    Time frame: from CPAP initiation until 6 months after CPAP treatment initiation

  2. Time course evolution of phone usage habits indices and evolution of depression

    Assessment of depression by Pichot scale

    Time frame: from CPAP initiation until 6 months after CPAP treatment initiation

  3. Time course evolution of phone usage habits indices and evolution of quality of life

    Assessment of quality of life by SF-36

    Time frame: from CPAP initiation until 6 months after CPAP treatment initiation

  4. Time course evolution of phone usage habits indices and evolution of locomotion

    patterns of locomotion objectively measured by a gait platform

    Time frame: from CPAP initiation until 6 months after CPAP treatment initiation

  5. CPAP adherence

    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

  6. Access to care as a predictor of CPAP adherence

    Care access questionnaire developed by ODENORE and National French insurance

    Time frame: from CPAP initiation until 6 months after CPAP treatment initiation

  7. Effect of food habit with CPAP treatment

    Changes in food frequence questionnaire

    Time frame: At CPAP initiation and at 6 months after CPAP treatment initiation

07

Study locations

1 site
  • Grenoble Alps University Hospital
    Grenoble, Rhône Alpes 38000, France
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03537066
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
May 25, 2018
Start date
Apr 10, 2018
Primary completion
Oct 10, 2018
Completion
Jun 15, 2021
Last update
May 24, 2022

Study contacts

Jean-Louis PEPIN
principal investigator · CHU Grenoble Alpes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion