Brief Summary

Continuous positive airway pressure (CPAP) is the first-line treatment for obstructive sleep apnea syndrome (OSA). It consists of a pressure generator connected to a mask applied to the patient's face. CPAP treatment is restrictive, and nearly a quarter of patients abandon it over the long term. Various factors can influence adherence to CPAP therapy, including adverse events associated with the mask. However, it is clear that compliance with CPAP treatment, even if it has tended to improve over the last 30 years, is still sub-optimal. The "Air Liquide Medical Systems" company has developed a mask that aims to improve comfort and ease of use for the patient. This leaky nasal mask has a "silent" intentional leak port, which significantly reduces the noise caused by the escape of air. The noise associated with intentional leakage is one of the discomforts reported by patients and their spouses. In addition, this mask is equipped with a new generation headgear with adjustment indicators to assist the patient in fitting the mask. Optimal headgear fit is a prerequisite for comfort during treatment, as it reduces unintentional leakage. The main objective is to evaluate, through a questionnaire, the comfort and general appreciation of a nasal mask equipped with a silent leak system and a headgear with adjustment aids, of patients with OSA treated with CPAP. Secondary objectives are :

1.To evaluate the appearance of CPAP side effects related to the mask,
2.To collect the patient's appreciation of the mask headgear,
3.To evaluate the discomfort caused by the nasal obstruction reported by the patient,
4.To evaluate the daytime sleepiness of the patient,
5.To study the parameters of the CPAP treatment.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for all trials

Timeline

Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

completed

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

4 months study duration

First Submitted

Initial submission to the registry

June 8, 2021

Completed

6 days until next milestone

First Posted

Study publicly available on registry

June 14, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

September 22, 2021

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2022

Completed

Last Updated

February 1, 2023

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

June 8, 2021

Last Update Submit

January 30, 2023

Conditions

Apnea, Obstructive

Keywords

Obstructive Sleep ApneaContinuous Positive Airway PressureMask

Outcome Measures

Primary Outcomes (1)

To evaluate the comfort and general appreciation of a nasal mask
to evaluate, through a questionnaire, the comfort and general appreciation of a nasal mask equipped with a silent leak system and a headgear with adjustment aids, of patients with OSA treated with CPAP.
After 30 days of CPAP treatment

Secondary Outcomes (7)

To evaluate the appearance of CPAP side effects related to the mask
After 30 days of CPAP treatment
To collect the patient's appreciation of the mask headgear
After 30 days of CPAP treatment
To evaluate the discomfort caused by the nasal obstruction reported by the patient
After 30 days of CPAP treatment
To evaluate the daytime sleepiness of the patient
After 30 days of CPAP treatment
To collect the CPAP treatment compliance
During the 30 days of CPAP treatment
+2 more secondary outcomes

Study Arms (1)

OSA patients treated with CPAP

OSA patient, not previously treated with CPAP, are treated with a "ResMed Airsense 10" CPAP and an "Air Liquide Medical Systems" NINA mask during 30 days, monitored by the home care provider AGIRADOM. After 30 days of CPAP treatment, 4 self-questionnaires are completed by the patient and parameters of the CPAP treatment (compliance, estimated unintentional leakage and therapeutic pressures) are collected.

Other: Self-questionnaire on the comfort and general appreciation of a nasal maskOther: Self-questionnaire on the appearance of CPAP side effects related to the maskOther: Self-questionnaire on the patient's appreciation of the mask headgear,Other: Self-questionnaire NOSE on the discomfort caused by the nasal obstructionOther: Self-questionnaire Epworth on the daytime sleepinessOther: To study the CPAP complianceOther: To study the unintentional leakageOther: To study the therapeutic pressures of CPAP