NCT04547543

Brief Summary

Prospective multicenter open-label randomized clinical trial comparing videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 7, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

January 22, 2024

Status Verified

January 1, 2024

Enrollment Period

5.5 years

First QC Date

September 7, 2020

Last Update Submit

January 19, 2024

Conditions

Obstructive Sleep Apnea

Keywords

TelemedicineMedical follow-up

Outcome Measures

Primary Outcomes (3)

  • Therapeutic adherence to CPAP

    Non inferiority of visioconsultation compared to face-to-face consultation in terms of therapeutic adherence to CPAP evaluated by the difference in compliance 3 months before and 3 months after the consultation

    3 months after consultation

  • Consultation cost

    Non inferiority of visioconsultation compared to face-to-face consultation in terms of consultation cost evaluated by the difference in cost between the 2 types of consultation

    3 months after consultation

  • Patient satisfaction: questionnaire

    Non inferiority of visioconsultation compared to face-to-face consultation in terms of patient satisfaction evaluated by the VSQ-VF questionnaire

    3 months after consultation

Secondary Outcomes (9)

  • Sleepiness related to CPAP

    3 and 12 after consultation

  • Tiredness related to CPAP

    3 and 12 months after consultation

  • Evaluate the quality of CPAP treatment (Residual AHI)

    3 and 12 months after consultation

  • Evaluate the quality of CPAP treatment (adverse events)

    3 and 12 months after consultation

  • Evaluate the quality of CPAP treatment (mask leaks level)

    3 and 12 months after consultation

  • +4 more secondary outcomes

Study Arms (2)

Video consultation

OTHER

Patients in this group will have a continuous positive pressure follow-up visit by videoconsultation

Other: Videoconsultation

Face-to-face consultation

NO INTERVENTION

Patients in this group will have a continuous positive pressure follow-up visit by face-to-face consultation

Interventions

VideoconsultationOTHER

Patient randomized on video-consultation group will have a video-consultation with the investigator within 3 months after the randomization. During this consultation, the investigator performs a clinical interrogation in order to collect anthropometric parameters: (sex, age, weight, height, body mass index (BMI)), blood pressure (by blood pressure monitor at home), the level of physical activity (by Actimetry over 7 days), smoking status and alcohol status

Video consultation

Eligibility Criteria

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

You may qualify if:

  • Apneic patient treated with CPAP for more than 12 months and having an annual scheduled follow-up visit.
  • Adult patient who can give an informed consent.
  • Patient with access to a media (Smartphone, tablet or computer) and an Internet connection at home.

You may not qualify if:

  • Patient unable to use or understand the digital system.
  • Patient under guardianship or deprived of liberty
  • Pregnant woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Grenoble-Alpes

Grenoble, 38043, France

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Renaud TAMISIER, Pr

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie JOYEUX-FAURE, Dr

CONTACT

+33 (0)4.76.76.71.66mjoyeuxfaure@chu-grenoble.fr

Renaud TAMISIER, Pr

CONTACT

+33 (0)4.76.76.84.69rtamisier@chu-grenoble.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2020

First Posted

September 14, 2020

Study Start

September 8, 2020

Primary Completion

March 1, 2026

Study Completion

March 1, 2026

Last Updated

January 22, 2024

Record last verified: 2024-01

Locations

FR(1)