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

Neuromuscular Diseases Clinical Trial

— InterfaceNMD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458507
• Other study ID #: 38RC17.346
• Status: Completed
• Phase: N/A
• Start date: May 28, 2018
• Est. completion date: June 26, 2019

Study information

• Verified date: October 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 26, 2019
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alveolar Hypoventilation
• Hypoventilation
• Neuromuscular Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Grenoble-Alpes University hospital	Grenoble

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Association Française contre les Myopathies (AFM), Paris, Hôpital Raymond Poincaré

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

Borel JC, Gakwaya S, Masse JF, Melo-Silva CA, Sériès 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean nocturnal oxygen saturation (SpO2)	Mean nocturnal SpO2, measured by oximetry.	After one week with each type of mask
Secondary	% 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
Secondary	Oxygen Desaturation Index	Oxygen desaturation index between oronasal mask versus nasal mask	After one week with each type of mask
Secondary	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
Secondary	Mean mouth opening during sleep	Mean mouth opening during sleep between oronasal mask versus nasal mask	After one week with each type of mask
Secondary	Non-intentional leaks	Non-intentional leaks recorded by the NIV-device	After one week with each type of mask
Secondary	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