NCT04925739

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: AGIR à Dom · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Apnea, Obstructive

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-09-22
• Primary completion: 2022-01-21
• Completion: 2022-01-21
• First posted: 2021-06-14
• Last updated: 2023-02-01

Locations

1 site across 1 country: France