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

A

AGIR à Dom

Status

Completed

Conditions

Apnea, Obstructive

Treatments

Other: To study the CPAP compliance

Other: To study the therapeutic pressures of CPAP

Other: Self-questionnaire on the patient's appreciation of the mask headgear,

Other: Self-questionnaire Epworth on the daytime sleepiness

Other: Self-questionnaire NOSE on the discomfort caused by the nasal obstruction

Other: Self-questionnaire on the appearance of CPAP side effects related to the mask

Other: To study the unintentional leakage

Other: Self-questionnaire on the comfort and general appreciation of a nasal mask

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT04925739

RCB : 2021-A01510-41

Details and patient eligibility

About

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 :

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

Full 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 :

To evaluate the appearance of CPAP side effects related to the mask (air leaks, injury to the nasal bridge, etc.)
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.
To evaluate the discomfort caused by the nasal obstruction reported by the patient, in relation to the inclusion.
To evaluate the daytime sleepiness of the patient, compared to the inclusion.
To study the parameters of the CPAP treatment.

Trial design

20 participants in 1 patient group

OSA patients treated with CPAP

Description:

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.

Treatment: