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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-22

Study Completion Date

2022-01-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Apnea, Obstructive

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

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

Intervention Type OTHER

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

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

Intervention Type OTHER

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

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

Intervention Type OTHER

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.

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

Intervention Type OTHER

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

Self-questionnaire Epworth on the daytime sleepiness

Intervention Type OTHER

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.

To study the CPAP compliance

Intervention Type OTHER

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

To study the unintentional leakage

Intervention Type OTHER

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

To study the therapeutic pressures of CPAP

Intervention Type OTHER

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

Interventions

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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

Intervention Type 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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

To study the unintentional leakage

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

Intervention Type OTHER

To study the therapeutic pressures of CPAP

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No