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

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:

1. the application of oronasal mask may jeopardize the pharyngeal patency in patients already proned to upper airway obstruction;
2. 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.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Diseases; Alveolar Hypoventilation
• Intervention / Treatment: Device: Switch of nocturnal NIV interface

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38000
    • Grenoble-Alpes University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual interface; 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.	Device: Switch of nocturnal NIV interface; 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.; Interface switch; 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.
Active Comparator: Alternative interface; 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.	Device: Switch of nocturnal NIV interface; 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.; Interface switch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean nocturnal oxygen saturation (SpO2)	Mean nocturnal SpO2, measured by oximetry.	After one week with each type of mask

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
% sleep recording with SpO2<90%	Percentage of sleep recording spent with SpO2<90% between oronasal mask versus nasal mask	After one week with each type of mask
Oxygen Desaturation Index	Oxygen desaturation index between oronasal mask versus nasal mask	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	After one week with each type of mask
Mean mouth opening during sleep	Mean mouth opening during sleep between oronasal mask versus nasal mask	After one week with each type of mask
Non-intentional leaks	Non-intentional leaks recorded by the NIV-device	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)	After one week with each type of mask

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Hôpital Raymond Poincaré; Association Française contre les Myopathies (AFM), Paris

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): June 26, 2019

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: October 7, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Non-invasive ventilation; Side effects; Nasal mask; Neuromuscular diseases; Oronasal mask; Alveolar hypoventilation; leaks; Sleep disorder breathing
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Hypoventilation; Neuromuscular Diseases
• Other Study ID Numbers: 38RC17.346

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No