Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of OSA Syndrome

Completed

• Conditions: Apnea, Obstructive
• Interventions: Other: Self-questionnaire on the comfort and general appreciation of a nasal mask; Other: Self-questionnaire on the appearance of CPAP side effects related to the mask; Other: Self-questionnaire on the patient's appreciation of the mask headgear,; Other: Self-questionnaire NOSE on the discomfort caused by the nasal obstruction; Other: Self-questionnaire Epworth on the daytime sleepiness; Other: To study the CPAP compliance; Other: To study the unintentional leakage; Other: To study the therapeutic pressures of CPAP

• Registration Number: NCT04925739
• Lead Sponsor: AGIR à Dom

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.

Detailed Description

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. Unintentional leaks, i.e. a leak between the pressure generator and the patient's upper airway, are among the most frequent. Therefore, optimizing the choice of mask is one of the main means used by medical-technical providers, in charge of installing CPAP and its technical follow-up at home. In order to cover the needs and anatomical particularities of the OSA patient population treated with CPAP, a large number of mask types and sizes are currently available on the market. 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.

After 30 days of use, secondary objectives are :

1. To evaluate the appearance of CPAP side effects related to the mask (air leaks, injury to the nasal bridge, etc.)

2. To collect the patient's appreciation of the mask headgear, which includes indications to help with the installation in the form of graduated markers, as well as the appreciation of the general aesthetics of the mask.

3. To evaluate the discomfort caused by the nasal obstruction reported by the patient, in relation to the inclusion.

4. To evaluate the daytime sleepiness of the patient, compared to the inclusion.

5. To study the parameters of the CPAP treatment.

Study Timeline

• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-14
• Study Start: 2021-09-22
• Status Verified: 2022-01
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-21
• Last Update Submitted: 2023-01-30
• Last Update Posted: 2023-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Male or female patient over 18 years of age
• Patient with OSA
• Patient not previously treated with CPAP
• A patient who will be treated with a "ResMed Airsense 10" CPAP and an "Air Liquide Medical Systems" NINA mask
• Patient whose CPAP treatment will be installed and monitored by the home care provider AGIRADOM
• Patient willing to participate in the research after adequate information and delivery of the information note
• Patient affiliated to the social security system or beneficiary of such a system

Exclusion Criteria

• NOSE questionnaire score greater than or equal to 10/20 at the time of CPAP installation
• Patient with significant craniofacial deformities that do not allow the mask to be fitted correctly
• Person deprived of liberty by judicial or administrative decision, person under legal protection (patient under guardianship or curators) Article L1121-8
• Subject who receives more than 4500 euros in compensation for his or her participation in other research involving the human person in the 12 months preceding this study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OSA patients treated with CPAP	Self-questionnaire on the comfort and general appreciation of a nasal mask	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.
OSA patients treated with CPAP	Self-questionnaire on the patient's appreciation of the mask headgear,	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.
OSA patients treated with CPAP	To study the therapeutic pressures of 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.
OSA patients treated with CPAP	Self-questionnaire Epworth on the daytime sleepiness	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.
OSA patients treated with CPAP	Self-questionnaire on the appearance of CPAP side effects related to the mask	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.
OSA patients treated with CPAP	To study the CPAP compliance	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.
OSA patients treated with CPAP	Self-questionnaire NOSE on the discomfort caused by the nasal obstruction	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.
OSA patients treated with CPAP	To study the unintentional leakage	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.

Primary Outcome Measures

Name	Time	Method
To evaluate the comfort and general appreciation of a nasal mask	After 30 days of CPAP treatment	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 Outcome Measures

Name	Time	Method
To evaluate the appearance of CPAP side effects related to the mask	After 30 days of CPAP treatment	To evaluate the appearance of CPAP side effects, through a questionnaire, related to the mask (air leaks, injury to the nasal bridge, etc.)
To collect the patient's appreciation of the mask headgear	After 30 days of CPAP treatment	To collect, through a questionnaire, the patient's appreciation of the mask headgear, which includes indications to help with the installation in the form of graduated markers, as well as the appreciation of the general aesthetics of the mask.
To evaluate the discomfort caused by the nasal obstruction reported by the patient	After 30 days of CPAP treatment	To evaluate, trough the NOSE questionnaire, the discomfort caused by the nasal obstruction reported by the patient, compared to the inclusion.
To evaluate the daytime sleepiness of the patient	After 30 days of CPAP treatment	To evaluate the daytime sleepiness of the patient, through the Epworth questionnaire, compared to the inclusion.
To collect the CPAP treatment compliance	During the 30 days of CPAP treatment	To collect the treatment compliance (average daily use) through telemonitoring of the data recorded by the CPAP machine.
To collect the unintentional leakage	During the 30 days of CPAP treatment	To collect the unintentional leakage estimated by the CPAP machine.
To collect the CPAP therapeutic pressures	During the 30 days of CPAP treatment	To collect the CPAP therapeutic pressures used.

Trial Locations

Locations (1)

Pauline Socquet; 🇫🇷 Meylan, France