Apnea, ObstructiveNINADOMNCT04925739
Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of OSA Syndrome
An observational study of Apnea, Obstructive, run by AGIR à Dom at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Apnea, Obstructive
- What is being tested?
- Self-questionnaire on the comfort and general appreciation of a nasal mask, Self-questionnaire on the appearance of CPAP side effects related to the mask and Self-questionnaire on the patient's appreciation of the mask headgear,
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 22 Sep 2021to 21 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
Read more
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 :
- To evaluate the appearance of CPAP side effects related to the mask,
- To collect the patient's appreciation of the mask headgear,
- To evaluate the discomfort caused by the nasal obstruction reported by the patient,
- To evaluate the daytime sleepiness of the patient,
- To study the parameters of the CPAP treatment.
Read the 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 :
- To evaluate the appearance of CPAP side effects related to the mask (air leaks, injury to the nasal bridge, etc.)
- 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.
- To evaluate the discomfort caused by the nasal obstruction reported by the patient, in relation to the inclusion.
- To evaluate the daytime sleepiness of the patient, compared to the inclusion.
- To study the parameters of the CPAP treatment.
- Conditions
- Apnea, Obstructive
- Being tested
- Self-questionnaire on the comfort and general appreciation of a nasal mask, Self-questionnaire on the appearance of CPAP side effects related to the mask, Self-questionnaire on the patient's appreciation of the mask headgear,, Self-questionnaire NOSE on the discomfort caused by the nasal obstruction, Self-questionnaire Epworth on the daytime sleepiness
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Mask
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-questionnaire on the comfort and general appreciation of a nasal maskOther
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 maskOther
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,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 obstructionOther
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 sleepinessOther
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 complianceOther
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 leakageOther
To collect the unintentional leakage estimated by the CPAP machine, during the 30 days of treatment.
To study the therapeutic pressures of CPAPOther
To collect the therapeutic pressures of CPAP, during the 30 days of treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Self-questionnaire on the comfort and general appreciation of a nasal mask; Other: Self-questionnaire on the appearance of CPAP side effects related to the mask; Other: Self-questionnaire on the patient's appreciation of the mask headgear,; Other: Self-questionnaire NOSE on the discomfort caused by the nasal obstruction; Other: Self-questionnaire Epworth on the daytime sleepiness; Other: To study the CPAP compliance; Other: To study the unintentional leakage; Other: To study the therapeutic pressures of CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 30 days of CPAP treatment
Secondary outcomes (7)
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.)
Measured: After 30 days of CPAP treatment
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.
Measured: After 30 days of CPAP treatment
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.
Measured: After 30 days of CPAP treatment
To evaluate the daytime sleepiness of the patient
To evaluate the daytime sleepiness of the patient, through the Epworth questionnaire, compared to the inclusion.
Measured: After 30 days of CPAP treatment
To collect the CPAP treatment compliance
To collect the treatment compliance (average daily use) through telemonitoring of the data recorded by the CPAP machine.
Measured: During the 30 days of CPAP treatment
To collect the unintentional leakage
To collect the unintentional leakage estimated by the CPAP machine.
Measured: During the 30 days of CPAP treatment
To collect the CPAP therapeutic pressures
To collect the CPAP therapeutic pressures used.
Measured: During the 30 days of CPAP treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start22 Sep 2021
- Primary completion21 Jan 2022
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AGIR à Dom
- Sponsor type
- University, hospital or other
- Collaborators
- Air Liquide SA
- Responsible party
- Sponsor
- Investigators
- LEBRET Marius, Study director, AIR LIQUIDE MEDICAL SYSTEMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925739
- Sponsor's protocol ID
- RCB : 2021-A01510-41
- Acronym
- NINADOM
- Status last verified
- Jan 2022
- First submitted
- 8 Jun 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Comfort of a Continuous Positive Airway Pressure Nasal Mask in the Treatment of Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT04925739
- Acronym / sponsor ID
- NINADOM / RCB : 2021-A01510-41
- Conditions
- Apnea, Obstructive
- Keywords
- Obstructive Sleep Apnea, Continuous Positive Airway Pressure, Mask
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AGIR à DomUniversity, hospital or other
- Collaborators
- Air Liquide SA
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- To evaluate the appearance of CPAP side effects related to the mask,
- To collect the patient's appreciation of the mask headgear,
- To evaluate the discomfort caused by the nasal obstruction reported by the patient,
- To evaluate the daytime sleepiness of the patient,
- 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 :
- To evaluate the appearance of CPAP side effects related to the mask (air leaks, injury to the nasal bridge, etc.)
- 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.
- To evaluate the discomfort caused by the nasal obstruction reported by the patient, in relation to the inclusion.
- To evaluate the daytime sleepiness of the patient, compared to the inclusion.
- To study the parameters of the CPAP treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OSA patients treated with CPAP | – | Other: Self-questionnaire on the comfort and general appreciation of a nasal mask, Other: Self-questionnaire on the appearance of CPAP side effects related to the mask, Other: Self-questionnaire on the patient's appreciation of the mask headgear,, Other: Self-questionnaire NOSE on the discomfort caused by the nasal obstruction, Other: Self-questionnaire Epworth on the daytime sleepiness, Other: To study the CPAP compliance, Other: To study the unintentional leakage, Other: To study the therapeutic pressures of CPAPOSA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-questionnaire on the comfort and general appreciation of a nasal maskSelf-questionnaire on the comfort and general appreciation of a nasal mask after 30 days of use | Other | OSA patients treated with CPAP |
| Self-questionnaire on the appearance of CPAP side effects related to the maskSelf-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 | OSA patients treated with CPAP |
| 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 | OSA patients treated with CPAP |
| Self-questionnaire NOSE on the discomfort caused by the nasal obstructionSelf-questionnaire NOSE on the discomfort caused by the nasal obstruction reported by the patient, after 30 days of use, compared to the inclusion. | Other | OSA patients treated with CPAP |
| Self-questionnaire Epworth on the daytime sleepinessSelf-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 | OSA patients treated with CPAP |
| To study the CPAP complianceTo collect the treatment compliance through telemonitoring of the data recorded by the CPAP machine, during the 30 days of treatment. | Other | OSA patients treated with CPAP |
| To study the unintentional leakageTo collect the unintentional leakage estimated by the CPAP machine, during the 30 days of treatment. | Other | OSA patients treated with CPAP |
| To study the therapeutic pressures of CPAPTo collect the therapeutic pressures of CPAP, during the 30 days of treatment. | Other | OSA patients treated with CPAP |
Primary outcome
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.
7 secondary outcomes
To evaluate the appearance of CPAP side effects related to the mask
Time frame: 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 evaluate the discomfort caused by the nasal obstruction reported by the patient
Time frame: After 30 days of CPAP treatment
To evaluate the daytime sleepiness of the patient
Time frame: After 30 days of CPAP treatment
To collect the CPAP treatment compliance
Time frame: During the 30 days of CPAP treatment
To collect the unintentional leakage
Time frame: During the 30 days of CPAP treatment
To collect the CPAP therapeutic pressures
Time frame: During the 30 days of CPAP treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEBRET Marius study director
AIR LIQUIDE MEDICAL SYSTEMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Apnea, Obstructive, run by AGIR à Dom at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the comfort and general appreciation of a nasal mask (time frame: After 30 days of CPAP treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.