Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy

NCT ID: NCT04391699

Last Updated: 2020-05-18

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-30

Study Completion Date

2019-07-31

Brief Summary

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To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

Detailed Description

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To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

Conditions

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Osa Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CPAP + Heated humidification

CPAP + Heated humidification

Group Type EXPERIMENTAL

heated humidification

Intervention Type DEVICE

heated humidification system

CPAP alone

CPAP

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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heated humidification

heated humidification system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult Patient
* Newly diagnosed OSA Patients eligible to CPAP therapy
* Signed informed consent

Exclusion Criteria

* CPAP therapy contraindications
* Pregnancy
* Patient unable to come to study follow up visits or unable to finish the study.
* Informed consent not signed
* Adults who are subject to a legal protection measure or are unable to express their consent (such as patients under guardianship and patients deprived of judicial or administrative freedom)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DOM AIR

UNKNOWN

Sponsor Role collaborator

ResMed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathalie Raymond, MD

Role: PRINCIPAL_INVESTIGATOR

clinique Bel Air

Locations

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Clinique Bel Air

Bordeaux, , France

Site Status

Countries

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France

Other Identifiers

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Humidifier 001

Identifier Type: -

Identifier Source: org_study_id

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