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| Name | Class |
|---|---|
| Association Française contre les Myopathies (AFM), Paris | OTHER |
| Hôpital Raymond Poincaré | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Switch of nocturnal NIV interface | Device |
The PtcCO2 device will be calibrated before and at the end of each night to allow drift correction. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean nocturnal oxygen saturation (SpO2) | Mean nocturnal SpO2, measured by oximetry. | After one week with each type of mask |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grenoble-Alpes University hospital | Grenoble | 38000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23691209 | Background | 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. | |
| 21800222 |
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| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D007040 | Hypoventilation |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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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.
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| 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 |
| 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. |
| 22772315 | 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. |
| 15083762 | 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. |
| 23787424 | 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. |
| 25142771 | 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. |
| 35725863 | Derived | 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. |
| 32586702 | 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. |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |