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

NCT03458507 | Completed DMC

• 1 other identifier: 38RC17.346
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neuromuscular Diseases; Alveolar Hypoventilation

Keywords

Neuromuscular diseases; Non-invasive ventilation; Nasal mask; Oronasal mask; Alveolar hypoventilation; leaks; Sleep disorder breathing; Side effects

Outcome Measures

Primary Outcomes (1)

• Mean nocturnal oxygen saturation (SpO2)

  Mean nocturnal SpO2, measured by oximetry.

  After one week with each type of mask

Secondary Outcomes (6)

• % sleep recording with SpO2<90%

  After one week with each type of mask

• Oxygen Desaturation Index

  After one week with each type of mask

• Mean nocturnal PtcCO2

  After one week with each type of mask

• Mean mouth opening during sleep

  After one week with each type of mask

• Non-intentional leaks

  After one week with each type of mask

Study Arms (2)

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.

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.

Device: Switch of nocturnal NIV interface

Interventions

Switch of nocturnal NIV interface DEVICE

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.

Alternative interface; Usual interface

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Vulnerable person or legally protected adult.

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Association Française contre les Myopathies (AFM), Paris: collaborator
• Hôpital Raymond Poincaré: collaborator

Study Sites (1)

Grenoble-Alpes University hospital

Grenoble, 38000, France

Location

Related Publications (8)

• 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.

  PMID: 23691209 BACKGROUND

• 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.

  PMID: 21800222 BACKGROUND

• 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.

  PMID: 22772315 BACKGROUND

• 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.

  PMID: 15083762 BACKGROUND

• 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.

  PMID: 23787424 BACKGROUND

• 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.

  PMID: 25142771 BACKGROUND

• 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.

  PMID: 35725863 DERIVED

• 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.

  PMID: 32586702 DERIVED

MeSH Terms

Conditions

Neuromuscular Diseases; Hypoventilation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 8, 2018
• Study Start: May 28, 2018
• Primary Completion: June 28, 2018
• Study Completion: June 26, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)