NCT03537066

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

April 10, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2018

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

May 24, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

March 28, 2018

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Time course evolution of phone usage habits indices and evolution of sleepiness

    from CPAP initiation until 6 months after CPAP treatment initiation

  • Time course evolution of phone usage habits indices and evolution of depression

    from CPAP initiation until 6 months after CPAP treatment initiation

  • Time course evolution of phone usage habits indices and evolution of quality of life

    from CPAP initiation until 6 months after CPAP treatment initiation

  • Time course evolution of phone usage habits indices and evolution of locomotion

    from CPAP initiation until 6 months after CPAP treatment initiation

  • CPAP adherence

    from CPAP initiation until 6 months after CPAP treatment initiation

  • +2 more secondary outcomes

Study Arms (1)

CPAP treatment

OTHER

All included OSA patients are going to be treated by CPAP

Device: CPAP

Interventions

CPAPDEVICE

All patients included will be treated by CPAP

CPAP treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grenoble Alps University Hospital

Grenoble, Auvergne-Rhône-Alpes, 38000, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Jean-Louis PEPIN

    CHU Grenoble Alpes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2018

First Posted

May 25, 2018

Study Start

April 10, 2018

Primary Completion

October 10, 2018

Study Completion

June 15, 2021

Last Updated

May 24, 2022

Record last verified: 2022-05

Locations