Follow-up of Apneic Patients by Visio-consultation

NCT ID: NCT04547543

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-08

Study Completion Date

2026-03-31

Brief Summary

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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) .

Detailed Description

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The annual management of Obstructive Sleep Apnea (OSA) patients treated by continuous positive air pressure (CPAP) aims to maintain an optimal level of care while offering to the patients a combined management of their pathology. This management aims to reduce the risk of cardio-metabolic pathologies.

However, the high prevalence of OSA in the general population reduces the ability to explore undiagnosed patients. The contribution of videoconsultation is now available and allows the management of OSA patients treated by CPAP.

The objective of this study is to compare the videoconsultation to a face-to-face consultation during the follow-up of apneic patients treated by continuous positive pressure (CPAP) .

The results of this study could provide very important new data on the impact of videoconsultation on the monitoring a chronic respiratory pathology such as sleep apnea.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Video consultation

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

Group Type OTHER

Videoconsultation

Intervention Type OTHER

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

Face-to-face consultation

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Videoconsultation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Patient unable to use or understand the digital system.
* Patient under guardianship or deprived of liberty
* Pregnant woman
* Patient in a period of exclusion from another clinical trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Renaud TAMISIER, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

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CHU Grenoble-Alpes

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marie JOYEUX-FAURE, Dr

Role: CONTACT

+33 (0)4.76.76.71.66

Renaud TAMISIER, Pr

Role: CONTACT

+33 (0)4.76.76.84.69

Facility Contacts

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Robin TERRAIL

Role: primary

Other Identifiers

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38RC19.312

Identifier Type: -

Identifier Source: org_study_id

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