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

June 8, 2021 updated by: AGIR à Dom

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

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.

Air Liquide Medical Systems 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / 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.

Air Liquide Medical Systems 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.

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Meylan, France, 38 240
        • AGIRADOM
        • Contact:
        • Principal Investigator:
          • Jean-Christian BOREL, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 curatorship) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the comfort and general appreciation of a nasal mask
Time Frame: After 30 days of CPAP treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the appearance of CPAP side effects related to the mask
Time Frame: After 30 days of CPAP treatment
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
To collect the patient's appreciation of the mask headgear
Time Frame: After 30 days of CPAP treatment
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
To evaluate the discomfort caused by the nasal obstruction reported by the patient
Time Frame: After 30 days of CPAP treatment
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
To evaluate the daytime sleepiness of the patient
Time Frame: After 30 days of CPAP treatment
To evaluate the daytime sleepiness of the patient, through the Epworth questionnaire, compared to the inclusion.
After 30 days of CPAP treatment
To collect the CPAP treatment compliance
Time Frame: During the 30 days of CPAP treatment
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
To collect the unintentional leakage
Time Frame: During the 30 days of CPAP treatment
To collect the unintentional leakage estimated by the CPAP machine.
During the 30 days of CPAP treatment
To collect the CPAP therapeutic pressures
Time Frame: During the 30 days of CPAP treatment
To collect the CPAP therapeutic pressures used.
During the 30 days of CPAP treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGIR à Dom

Collaborators

AIR LIQUIDE MEDICAL SYSTEMS

Investigators

  • Study Director: LEBRET Marius, AIR LIQUIDE MEDICAL SYSTEMS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 20, 2021

Primary Completion (Anticipated)

October 20, 2021

Study Completion (Anticipated)

November 20, 2021

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

June 14, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCB : 2021-A01510-41

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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