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

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.

Conditions

• Apnea, Obstructive

Interventions

OTHER

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

Self-questionnaire on the comfort and general appreciation of a nasal mask after 30 days of use

OTHER

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

Self-questionnaire on the appearance of CPAP side effects related to the mask (air leaks, injury to the nasal bridge, etc.) after 30 days of use

OTHER

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

Self-questionnaire NOSE (Nasal Obstruction Symptom Evaluation) on 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, after 30 days of use.

OTHER

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

Self-questionnaire NOSE on the discomfort caused by the nasal obstruction reported by the patient, after 30 days of use, compared to the inclusion.

OTHER

Self-questionnaire Epworth on the daytime sleepiness

Self-questionnaire Epworth on the daytime sleepiness of the patient, after 30 days of treatment, compared to the inclusion. To study the parameters of the CPAP treatment.

OTHER

To study the CPAP compliance

To collect the treatment compliance through telemonitoring of the data recorded by the CPAP machine, during the 30 days of treatment.

OTHER

To study the unintentional leakage

To collect the unintentional leakage estimated by the CPAP machine, during the 30 days of treatment.

OTHER

To study the therapeutic pressures of CPAP

To collect the therapeutic pressures of CPAP, during the 30 days of treatment.

Sponsors & Collaborators

• Air Liquide SA

  collaborator INDUSTRY

• AGIR à Dom

  lead OTHER

Principal Investigators

• LEBRET Marius · AIR LIQUIDE MEDICAL SYSTEMS

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-09-22

Primary Completion

2022-01-21

Completion

2022-01-21

Countries

• France

Study Locations