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

Apnea, Obstructive Clinical Trial

— NINADOM  

Official title:

Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04925739
• Other study ID #: RCB : 2021-A01510-41
• Status: Completed
• Start date: September 22, 2021
• Est. completion date: January 21, 2022

Study information

• Verified date: January 2022
• Source: AGIR à Dom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Apnea, Obstructive
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Pauline Socquet	Meylan

Sponsors (2)

Lead Sponsor	Collaborator
AGIR à Dom	Air Liquide SA

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the comfort and general appreciation of a nasal mask	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 CPAP treatment
Secondary	To evaluate the appearance of CPAP side effects related to the mask	To evaluate the appearance of CPAP side effects, through a questionnaire, related to the mask (air leaks, injury to the nasal bridge, etc.)	After 30 days of CPAP treatment
Secondary	To collect the patient's appreciation of the mask headgear	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.	After 30 days of CPAP treatment
Secondary	To evaluate the discomfort caused by the nasal obstruction reported by the patient	To evaluate, trough the NOSE questionnaire, the discomfort caused by the nasal obstruction reported by the patient, compared to the inclusion.	After 30 days of CPAP treatment
Secondary	To evaluate the daytime sleepiness of the patient	To evaluate the daytime sleepiness of the patient, through the Epworth questionnaire, compared to the inclusion.	After 30 days of CPAP treatment
Secondary	To collect the CPAP treatment compliance	To collect the treatment compliance (average daily use) through telemonitoring of the data recorded by the CPAP machine.	During the 30 days of CPAP treatment
Secondary	To collect the unintentional leakage	To collect the unintentional leakage estimated by the CPAP machine.	During the 30 days of CPAP treatment
Secondary	To collect the CPAP therapeutic pressures	To collect the CPAP therapeutic pressures used.	During the 30 days of CPAP treatment