Clinical trial NCT04925739: Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of OSA Syndrome
Official title: Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of Obstructive Sleep Apnea Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Apnea, Obstructive
Keywords: Obstructive Sleep Apnea
Continuous Positive Airway Pressure
Mask
Lead sponsor: AGIR à Dom
Sponsor class: OTHER
Collaborators: name: Air Liquide SA
First posted: 2021-06-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: OSA patient, not previously treated with CPAP, 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To evaluate the comfort and general appreciation of a nasal mask
timeFrame: After 30 days of CPAP treatment
Secondary outcomes:
measure: To evaluate the appearance of CPAP side effects related to the mask
timeFrame: After 30 days of CPAP treatment
measure: To collect the patient's appreciation of the mask headgear
timeFrame: After 30 days of CPAP treatment
measure: To evaluate the discomfort caused by the nasal obstruction reported by the patient
timeFrame: After 30 days of CPAP treatment
measure: To evaluate the daytime sleepiness of the patient
timeFrame: After 30 days of CPAP treatment
measure: To collect the CPAP treatment compliance
timeFrame: During the 30 days of CPAP treatment
measure: To collect the unintentional leakage
timeFrame: During the 30 days of CPAP treatment
measure: To collect the CPAP therapeutic pressures
timeFrame: During the 30 days of CPAP treatment
Other outcomes:
Locations:
city: Meylan
country: France
facility: Pauline Socquet
Study officials:
affiliation: AIR LIQUIDE MEDICAL SYSTEMS
name: LEBRET Marius
role: STUDY_DIRECTOR
References: