Obstructive Sleep ApneaNCT01889472
Impact of Interface With/Without Oral Appliance of Sleep Apnea Treatment
A study testing Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy in people with Obstructive Sleep Apnea, run by Laval University at 3 sites in 2 countries.
Trial summary
CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2013to 18 Jan 2017
- Phase
- Interventional
- 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
Who may be able to join
- normal nasal breathing
- dentition allowing for use of an oral appliance
- absence of mandibular joint pathology
- Patients requiring the use of a facial mask during CAPP titration due to presence of mouth leaks with a nasal/prong interface
- Patients using CPAP less than 3 hours/day as prescribed following CPAP titration
Who cannot join
- Clinical instability
- smoking cessation
- current weight loss strategy
- Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy)
- severe cardio-metabolic co-morbidity
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea
CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.
Read the detailed description
Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy
- Keywords
- CPAP compliance, leaks, Respiratory disturbances index, quality of life
- 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.
Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapyDevice
| Study group | Role | What they receive |
|---|---|---|
| oro-nasal mask | Active comparator | Oro-nasal mask during 1 month of auto CPAP Receives: Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy |
| Nasal mask and oral appliance | Experimental | Nasal mask and oral appliance during 1 month of auto CPAP Receives: Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP compliance
CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.
Measured: After 4 weeks of CPAP trial
Secondary outcomes (1)
diurnal somnolence
Epworth Sleepiness Score
Measured: After 4 weeks of CPAP trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJun 2013
- Primary completion18 Jan 2017
- Study completion18 Jan 2017
Why it stopped: Inability to further include additional patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frédéric Sériès, Laval University
- Investigators
- Frederic Series, MD, Principal investigator, Fondation IUCPQ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889472
- Sponsor's protocol ID
- MNB-003
- Other IDs
- JDBF-2012
- Status last verified
- May 2017
- First submitted
- 19 Jun 2013
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Borel JC, Tamisier R, Dias-Domingos S, Sapene M, Martin F, Stach B, Grillet Y, Muir JF, Levy P, Series F, Pepin JL; Scientific Council of The Sleep Registry of the French Federation of Pneumology (OSFP). Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One. 2013 May 15;8(5):e64382. doi: 10.1371/journal.pone.0064382. Print 2013.
PubMed 23691209Leotard A, Lesgoirres M, Daabek N, Lebret M, Bailly S, Verain A, Series F, Pepin JL, Borel JC. Adherence to CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask: a randomized crossover trial. Sleep Breath. 2019 Sep;23(3):885-888. doi: 10.1007/s11325-018-01772-5. Epub 2019 Jan 28.
PubMed 30689098
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Nasal Mask/Oronasal Mask on Compliance to Treatment With Continuous Positive Airway Pressure (CPAP) in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01889472
- Acronym / sponsor ID
- MNB-003
- Conditions
- Obstructive Sleep Apnea
- Keywords
- CPAP compliance, leaks, Respiratory disturbances index, quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to further include additional patients
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 28 Jun 2013 (estimated)
- 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.
CPAP is the most effective treatment of obstructive sleep apnea. Oro-nasal masks may be used in case of mouth leaks but these are associated with higher positive pressure needs and lower compliance to treatment. The present investigation evaluates if CPAP compliance would increase when an oral appliance is used in combination with a nasal mask compared to the use of an oro-nasal mask. Eligible patients are those demonstrating a low compliance when using an oro-nasal mask during CPAP therapy. Patients will be treated with automatic CPAP with one of the above-detailed interfaces for 4 weeks and data will be extracted from the machine report in each condition.
Detailed description
Participating subjects will be currently treated by CPAP and low compliance will be assessed according to machine report download demonstrating 3h or less of CPAP usage per night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oro-nasal mask | Active comparator | Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapyOro-nasal mask during 1 month of auto CPAP |
| Nasal mask and oral appliance | Experimental | Device: Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapyNasal mask and oral appliance during 1 month of auto CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- normal nasal breathing
- dentition allowing for use of an oral appliance
- absence of mandibular joint pathology
- Patients requiring the use of a facial mask during CAPP titration due to presence of mouth leaks with a nasal/prong interface
- Patients using CPAP less than 3 hours/day as prescribed following CPAP titration
Key exclusion criteria (5 listed)
- Clinical instability
- smoking cessation
- current weight loss strategy
- Marked anatomic abnormalities of upper airway (i.e. macroglossia, tonsils hypertrophy)
- severe cardio-metabolic co-morbidity
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 |
|---|---|---|
| Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy | Device | Nasal mask and oral appliance, oro-nasal mask |
Primary outcome
CPAP compliance
Time frame: After 4 weeks of CPAP trial
CPAP compliance will be assessed according to machine report download for the 4 weeks of treatment in each study condition.
1 secondary outcome
diurnal somnolence
Time frame: After 4 weeks of CPAP trial
Results and safety
The study was stopped early (reason given: Inability to further include additional patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Background: PubMed 23691209Borel JC, Tamisier R, Dias-Domingos S, Sapene M, Martin F, Stach B, Grillet Y, Muir JF, Levy P, Series F, Pepin JL; Scientific Council of The Sleep Registry of the French Federation of Pneumology (OSFP). Type of mask may impact on continuous positive airway pressure adherence in apneic patients. PLoS One. 2013 May 15;8(5):e64382. doi: 10.1371/journal.pone.0064382. Print 2013.
- Derived from this study: PubMed 30689098Leotard A, Lesgoirres M, Daabek N, Lebret M, Bailly S, Verain A, Series F, Pepin JL, Borel JC. Adherence to CPAP with a nasal mask combined with mandibular advancement device versus an oronasal mask: a randomized crossover trial. Sleep Breath. 2019 Sep;23(3):885-888. doi: 10.1007/s11325-018-01772-5. Epub 2019 Jan 28.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Frederic Series, MD principal investigator
Fondation IUCPQ
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy in people with Obstructive Sleep Apnea, run by Laval University at 3 sites in 2 countries.
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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada, 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 was stopped early (reason given: Inability to further include additional patients). Results are not available in the source record.
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?
CPAP compliance (time frame: After 4 weeks of CPAP trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01889472, which also lists 2 linked publications.
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 5 May 2017.