Impact of Tele-visit on Patients Continous Positive Airway Pressure (CPAP) Follow-up by Home Care Provider

NCT05653804 | Active Not Recruiting

• 1 other identifier: 2022-A02309-34
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the impact of telecare on continous positive airway pressure (CPAP) patients follow up by home care provider (HCP)

Conditions

Obstructive Sleep Apnea

Keywords

tele-visit

Outcome Measures

Primary Outcomes (1)

• To compare CPAP compliance between the two management modalities

  CPAP mean compliance between intervention and control groups, adjusted for the three months prior to inclusion : in hours/day, collected on the CPAP remote monitoring report

  Over the 3 months (tele)visit follow-up

Secondary Outcomes (13)

• To compare overall patient satisfaction between the two management modalities

  Immediately after the (tele-)visit follow-up

• To compare the impact on daytime sleepiness between the two management modalities

  At 3 months after (tele-)visit follow-up

• To compare impact on quality of life between the two management modalities

  At 3 months after (tele-)visit follow-up

• To compare CPAP compliance in medium term between the two management modalities

  Over the 12 months (tele)visit follow-up

• To compare impact on CPAP continuation between the two management modalities

  Over the 12 months (tele)visit follow-up

Other Outcomes (1)

• To evaluate patient overall satisfaction regarding clinical study participation

  Over the 3 months (tele)visit follow-up

Study Arms (2)

tele-visit by HCP

EXPERIMENTAL

Patients receive a annual CPAP remote visit by HCP technician, then home visit the following year

Procedure: tele-visit

home visit by HCP

NO INTERVENTION

Standard care : patients receive an annual CPAP home visit by HCP technician

Interventions

tele-visit PROCEDURE

The remote visit content for CPAP follow up is based on home visit framework and carried out from a secure platform for sharing health data.

tele-visit by HCP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• CPAP ≥ 12 months and annual followed by "AGIR à dom" health care provider.

You may not qualify if:

• Follow-up by AGIR à dom. for an other service than package F9.1 : CPAP follow-up and remote monitoring
• Unacceptable level of mask leakage
• Patient unavailable or willing to move within the next 12 months to an area not covered by AGIR à dom.
• Patient considered by the investigator to be unfit for a tele-visit

Sponsors & Collaborators

• AGIR à Dom: lead

Study Sites (1)

AGIR à dom.

Meylan, 38240, France

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean Christian BOREL, PhD

  AGIR à Dom

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, interventional, randomized controlled, open-label, single-center, multi-site

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 16, 2022
• Study Start: April 1, 2023
• Primary Completion: May 11, 2026
• Study Completion (Estimated): May 11, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-02

Locations

FR (1)