Neuromuscular DiseasesInterfaceNMDNCT03458507

Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation

A study testing Switch of nocturnal NIV interface in people with Neuromuscular Diseases and Alveolar Hypoventilation, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Neuromuscular Diseases, Alveolar Hypoventilation
What is being tested?: Switch of nocturnal NIV interface
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteFrance
Study dates: 28 May 2018to 26 Jun 2019
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult patients (>18 years old)
Affected by slowly progressive neuro-muscular diseases (Becker muscular dystrophy, facio-scapulo-humeral dystrophy, limb-girdle dystrophy, myotonic dystrophy…) or relatively rapid progression (Duchenne muscular dystrophy).
Treated with nocturnal non-invasive ventilation (<15 hours/day)
In stable state (no cardiorespiratory or ear-nose-throat event for at least 1 month before inclusion)

Who cannot join

Rapidly progressive neuro-muscular diseases (such as ALS)
Severe nasal obstruction, maxillofacial deformities or previous upper airway surgery preventing the usage of one type of mask (nasal or oronasal), or, at the discretion of investigator, any other contraindication for using the other type of mask
NIV Daily use >15h/day
Unwillingness or inability to provide consent to participation
Curatorship
Subject in exclusion period of another study
Vulnerable person or legally protected adult.

Trial locations and contacts

1 site in 1 country.

France1 site

Grenoble-Alpes University hospital
Grenoble, 38000

Other trials in France

About this study

Official title: Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation: a Randomized Crossover Trial

Nocturnal Non Invasive Ventilation (NIV) is the reference treatment for chronic alveolar hypoventilation in patients with neuro-muscular diseases. NIV can be provided by using different types of interfaces: Nasal masks are the most frequent type of interface used at home but oronasal masks are used by at least 25% of neuro-muscular patients mainly because of persistent unintentional mouth leaks. However, oronasal mask may cause persistent upper airway obstructive respiratory events because of the mechanical constraint on the chin induced by the traction of the straps that may push the mandible posteriorly during sleep.

No randomized study has specifically addressed the question of the impact of type of interface in patients with neuromuscular diseases treated by nocturnal NIV.

The investigators hypothesize that:

the application of oronasal mask may jeopardize the pharyngeal patency in patients already proned to upper airway obstruction;
the use of a nasal mask may improve upper airway stability and NIV efficacy while reducing side effects.

Authors objective will be to compare the impact of nasal mask versus oronasal mask on NIV efficacy and side-effects. Eligible patients are those with nocturnal NIV and neuromuscular disease.

After a scheduled hospital visit, patients willing to participate will undergo in random order 2 unattended nocturnal polygraphies under NIV at home: one polygraphy with nasal mask; one with an oronasal mask. Each polygraphy ans side effects assessment will be performed after one week of familiarization with each mask.

Conditions: Neuromuscular Diseases, Alveolar Hypoventilation
Being tested: Switch of nocturnal NIV interface
Keywords: Neuromuscular diseases, Non-invasive ventilation, Nasal mask, Oronasal mask, Alveolar hypoventilation, leaks, Sleep disorder breathing, Side effects
Medical subject headings: Neuromuscular Diseases, Hypoventilation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Switch of nocturnal NIV interfaceDevice
1. test the alternative interfaces (either a nasal mask for the patient used to oronasal mask or inversely an oronasal mask if the usual mask is nasal) during a one-hour diurnal NIV session. SpO2 (polygraphy), PtcCO2 will be monitored continuously during this diurnal session. Patients will use their usual NIV device prescribed at home. NIV settings will be adapted if needed.
2. Interface switch
3. unattended nocturnal polygraphy under NIV (cf details below) will be performed at home with SomnoHolter® (Nomics, Liege, Belgium), synchronized with transcutaneous partial pressure in CO2 (PtcCO2) monitoring by SenTec V-Sign™ System.
The PtcCO2 device will be calibrated before and at the end of each night to allow drift correction.

Study groups in NCT03458507
Study group	Role	What they receive
Usual interface	Active comparator	Patients which begin with their usual interface for one week, home polygraphy and side effect assessment at the end of the first week. Switch for alternative interface, seven days familiarisation, second polygraphy and side effect assessment at the end of the second week. Receives: Device: Switch of nocturnal NIV interface
Alternative interface	Active comparator	Patients which begin with the alternative interface for one week, home polygraphy and side effect assessment at the end of the first week. Switch for usual interface, seven days with usual device, second polygraphy and side effect assessment at the end of the second week. Receives: Device: Switch of nocturnal NIV interface

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean nocturnal oxygen saturation (SpO2)
Mean nocturnal SpO2, measured by oximetry.
Measured: After one week with each type of mask

Secondary outcomes (6)

% sleep recording with SpO2<90%
Percentage of sleep recording spent with SpO2<90% between oronasal mask versus nasal mask
Measured: After one week with each type of mask
Oxygen Desaturation Index
Oxygen desaturation index between oronasal mask versus nasal mask
Measured: After one week with each type of mask
Mean nocturnal PtcCO2
Mean nocturnal transcutaneous partial pressure in CO2 (PtcCO2) evaluated by capnography between oronasal mask versus nasal mask
Measured: After one week with each type of mask
Mean mouth opening during sleep
Mean mouth opening during sleep between oronasal mask versus nasal mask
Measured: After one week with each type of mask
Non-intentional leaks
Non-intentional leaks recorded by the NIV-device
Measured: After one week with each type of mask
Side-effects of Continuous Positive Airway Pressure (CPAP)
Side-effects reported by patients using a modified version of "Side Effect of CPAP inventory" (SECI) questionnaire.
A French translation will be done by two bilingual investigators (one medical doctor, one linguist).
This questionnaire consists of a list of 15 commonly reported side effects under CPAP.
For each side effect, the patient is asked to rate the frequency (0-5), magnitude (0-5) and perceived impact on adherence (0-5) on a five-point Likert-type scale.
Total score range : 0 to 225, with the higher score associated with the worst tolerance.
Range for each of the fifteen side effects: 0 to 15, higher values always represent a worse outcome (all subscales results are summed to compute the total score)
Measured: After one week with each type of mask

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 May 201826 Jun 2019

First posted8 Mar 2018
Study start28 May 2018
Primary completion28 Jun 2018
Study completion26 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
More trials run by University Hospital, GrenobleThe 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: Supportive care
Allocation: Randomised
Intervention model: Crossover
Model description: The patients will be randomized for two periods of one week to use NIV either with nasal or oronasal mask. The randomization will be stratified according to the type of interface previously used at home by the patient (nasal and oronasal). Such stratification will allow a balance between the number of patients that will begin with their usual interface versus with an alternative interface. In these patients, NIV withdrawal is not acceptable in terms of patient's security and ethics. Therefore, it is not possible to include a wash out period between both arms. The potential carry-over effect will be taken into account in the statistical analysis.
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03458507
Sponsor's protocol ID: 38RC17.346
Acronym: InterfaceNMD
Status last verified: Oct 2019
First submitted: 1 Mar 2018
Last updated: 8 Oct 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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 23691209
Bakker JP, Neill AM, Campbell AJ. Nasal versus oronasal continuous positive airway pressure masks for obstructive sleep apnea: a pilot investigation of pressure requirement, residual disease, and leak. Sleep Breath. 2012 Sep;16(3):709-16. doi: 10.1007/s11325-011-0564-3. Epub 2011 Jul 29.
PubMed 21800222
Borel JC, Gakwaya S, Masse JF, Melo-Silva CA, Series F. Impact of CPAP interface and mandibular advancement device on upper airway mechanical properties assessed with phrenic nerve stimulation in sleep apnea patients. Respir Physiol Neurobiol. 2012 Aug 15;183(2):170-6. doi: 10.1016/j.resp.2012.06.018. Epub 2012 Jul 3.
PubMed 22772315
Willson GN, Piper AJ, Norman M, Chaseling WG, Milross MA, Collins ER, Grunstein RR. Nasal versus full face mask for noninvasive ventilation in chronic respiratory failure. Eur Respir J. 2004 Apr;23(4):605-9. doi: 10.1183/09031936.04.00051604.
PubMed 15083762
Fleck RJ Jr, Mahmoud M, McConnell K, Shott SR, Gutmark E, Amin RS. An adverse effect of positive airway pressure on the upper airway documented with magnetic resonance imaging. JAMA Otolaryngol Head Neck Surg. 2013 Jun;139(6):636-8. doi: 10.1001/jamaoto.2013.3279.
PubMed 23787424
Vrijsen B, Buyse B, Belge C, Testelmans D. Upper airway obstruction during noninvasive ventilation induced by the use of an oronasal mask. J Clin Sleep Med. 2014 Sep 15;10(9):1033-5. doi: 10.5664/jcsm.4046.
PubMed 25142771
Leotard A, Delorme M, Hartley S, Khouri C, Lebret M, Lofaso F, Pepin JL, Borel JC. Non-invasive ventilation in neuromuscular diseases: should we use higher levels of ventilatory support? Sleep Breath. 2023 May;27(2):673-677. doi: 10.1007/s11325-022-02658-3. Epub 2022 Jun 20.
PubMed 35725863
Leotard A, Lebret M, Daabek N, Prigent H, Destors M, Saint-Raymond C, Sagniez A, Leroux K, Tamisier R, Lofaso F, Pepin JL, Borel JC. Impact of Interface Type on Noninvasive Ventilation Efficacy in Patients With Neuromuscular Disease: A Randomized Cross-Over Trial. Arch Bronconeumol (Engl Ed). 2021 Apr;57(4):273-280. doi: 10.1016/j.arbres.2020.05.024. Epub 2020 Jun 23. English, Spanish.
PubMed 32586702

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation: a Randomized Crossover Trial
ClinicalTrials.gov ID: NCT03458507
Acronym / sponsor ID: InterfaceNMD / 38RC17.346
Conditions: Neuromuscular Diseases, Alveolar Hypoventilation
Keywords: Neuromuscular diseases, Non-invasive ventilation, Nasal mask, Oronasal mask, Alveolar hypoventilation, leaks, Sleep disorder breathing, Side effects
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
Collaborators: Association Française contre les Myopathies (AFM), Paris, Hôpital Raymond Poincaré
Study start: 28 May 2018 (actual)
Primary completion: 28 Jun 2018 (actual)
Study completion: 26 Jun 2019 (actual)
First posted: 8 Mar 2018 (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.

No randomized study has specifically addressed the question of the impact of type of interface in patients with neuromuscular diseases treated by nocturnal NIV.

The investigators hypothesize that:

the application of oronasal mask may jeopardize the pharyngeal patency in patients already proned to upper airway obstruction;
the use of a nasal mask may improve upper airway stability and NIV efficacy while reducing side effects.

Authors objective will be to compare the impact of nasal mask versus oronasal mask on NIV efficacy and side-effects. Eligible patients are those with nocturnal NIV and neuromuscular disease.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: The patients will be randomized for two periods of one week to use NIV either with nasal or oronasal mask. The randomization will be stratified according to the type of interface previously used at home by the patient (nasal and oronasal). Such stratification will allow a balance between the number of patients that will begin with their usual interface versus with an alternative interface. In these patients, NIV withdrawal is not acceptable in terms of patient's security and ethics. Therefore, it is not possible to include a wash out period between both arms. The potential carry-over effect will be taken into account in the statistical analysis.

Arm	Type	Receives
Usual interface	Active comparator	Device: Switch of nocturnal NIV interfacePatients which begin with their usual interface for one week, home polygraphy and side effect assessment at the end of the first week. Switch for alternative interface, seven days familiarisation, second polygraphy and side effect assessment at the end of the second week.
Alternative interface	Active comparator	Device: Switch of nocturnal NIV interfacePatients which begin with the alternative interface for one week, home polygraphy and side effect assessment at the end of the first week. Switch for usual interface, seven days with usual device, second polygraphy and side effect assessment at the end of the second week.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Adult patients (>18 years old)
Affected by slowly progressive neuro-muscular diseases (Becker muscular dystrophy, facio-scapulo-humeral dystrophy, limb-girdle dystrophy, myotonic dystrophy…) or relatively rapid progression (Duchenne muscular dystrophy).
Treated with nocturnal non-invasive ventilation (<15 hours/day)
In stable state (no cardiorespiratory or ear-nose-throat event for at least 1 month before inclusion)

Key exclusion criteria (7 listed)

Rapidly progressive neuro-muscular diseases (such as ALS)
Severe nasal obstruction, maxillofacial deformities or previous upper airway surgery preventing the usage of one type of mask (nasal or oronasal), or, at the discretion of investigator, any other contraindication for using the other type of mask
NIV Daily use >15h/day
Unwillingness or inability to provide consent to participation
Curatorship

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
Switch of nocturnal NIV interface1. test the alternative interfaces (either a nasal mask for the patient used to oronasal mask or inversely an oronasal mask if the usual mask is nasal) during a one-hour diurnal NIV session. SpO2 (polygraphy), PtcCO2 will be monitored continuously during this diurnal session. Patients will use their usual NIV device prescribed at home. NIV settings will be adapted if needed. 2. Interface switch 3. unattended nocturnal polygraphy under NIV (cf details below) will be performed at home with SomnoHolter® (Nomics, Liege, Belgium), synchronized with transcutaneous partial pressure in CO2 (PtcCO2) monitoring by SenTec V-Sign™ System. The PtcCO2 device will be calibrated before and at the end of each night to allow drift correction.	Device	Alternative interface, Usual interface

Primary outcome

Mean nocturnal oxygen saturation (SpO2)
Time frame: After one week with each type of mask
Mean nocturnal SpO2, measured by oximetry.

6 secondary outcomes

% sleep recording with SpO2<90%
Time frame: After one week with each type of mask
Oxygen Desaturation Index
Time frame: After one week with each type of mask
Mean nocturnal PtcCO2
Time frame: After one week with each type of mask
Mean mouth opening during sleep
Time frame: After one week with each type of mask
Non-intentional leaks
Time frame: After one week with each type of mask
Side-effects of Continuous Positive Airway Pressure (CPAP)
Time frame: After one week with each type of mask

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 8 Oct 2019.
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.
Background: PubMed 21800222Bakker JP, Neill AM, Campbell AJ. Nasal versus oronasal continuous positive airway pressure masks for obstructive sleep apnea: a pilot investigation of pressure requirement, residual disease, and leak. Sleep Breath. 2012 Sep;16(3):709-16. doi: 10.1007/s11325-011-0564-3. Epub 2011 Jul 29.
Background: PubMed 22772315Borel JC, Gakwaya S, Masse JF, Melo-Silva CA, Series F. Impact of CPAP interface and mandibular advancement device on upper airway mechanical properties assessed with phrenic nerve stimulation in sleep apnea patients. Respir Physiol Neurobiol. 2012 Aug 15;183(2):170-6. doi: 10.1016/j.resp.2012.06.018. Epub 2012 Jul 3.
Background: PubMed 15083762Willson GN, Piper AJ, Norman M, Chaseling WG, Milross MA, Collins ER, Grunstein RR. Nasal versus full face mask for noninvasive ventilation in chronic respiratory failure. Eur Respir J. 2004 Apr;23(4):605-9. doi: 10.1183/09031936.04.00051604.
Background: PubMed 23787424Fleck RJ Jr, Mahmoud M, McConnell K, Shott SR, Gutmark E, Amin RS. An adverse effect of positive airway pressure on the upper airway documented with magnetic resonance imaging. JAMA Otolaryngol Head Neck Surg. 2013 Jun;139(6):636-8. doi: 10.1001/jamaoto.2013.3279.
Background: PubMed 25142771Vrijsen B, Buyse B, Belge C, Testelmans D. Upper airway obstruction during noninvasive ventilation induced by the use of an oronasal mask. J Clin Sleep Med. 2014 Sep 15;10(9):1033-5. doi: 10.5664/jcsm.4046.
Derived from this study: PubMed 35725863Leotard A, Delorme M, Hartley S, Khouri C, Lebret M, Lofaso F, Pepin JL, Borel JC. Non-invasive ventilation in neuromuscular diseases: should we use higher levels of ventilatory support? Sleep Breath. 2023 May;27(2):673-677. doi: 10.1007/s11325-022-02658-3. Epub 2022 Jun 20.
Derived from this study: PubMed 32586702Leotard A, Lebret M, Daabek N, Prigent H, Destors M, Saint-Raymond C, Sagniez A, Leroux K, Tamisier R, Lofaso F, Pepin JL, Borel JC. Impact of Interface Type on Noninvasive Ventilation Efficacy in Patients With Neuromuscular Disease: A Randomized Cross-Over Trial. Arch Bronconeumol (Engl Ed). 2021 Apr;57(4):273-280. doi: 10.1016/j.arbres.2020.05.024. Epub 2020 Jun 23. English, Spanish.
Individual participant dataSharing planned: No

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Switch of nocturnal NIV interface in people with Neuromuscular Diseases and Alveolar Hypoventilation, run by University Hospital, Grenoble 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 4 inclusion and 7 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 8 Oct 2019. 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?

Mean nocturnal oxygen saturation (SpO2) (time frame: After one week with each type of mask). 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 NCT03458507, which also lists 8 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 8 Oct 2019; AzTrials last refreshed its copy on 7 Nov 2026.