An interventional study of Switch of nocturnal NIV interface in Neuromuscular Diseases and Alveolar Hypoventilation, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-10-08.
Sponsored by University Hospital, Grenoble · Not applicable, Interventional, and Supportive care
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.
Exclusion Criteria:
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
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
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.
Mean nocturnal oxygen saturation (SpO2)
Mean nocturnal SpO2, measured by oximetry.
Time frame: After one week with each type of mask
% sleep recording with SpO2<90%
Percentage of sleep recording spent with SpO2\<90% between oronasal mask versus nasal mask
Time frame: After one week with each type of mask
Oxygen Desaturation Index
Oxygen desaturation index between oronasal mask versus nasal mask
Time frame: 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
Time frame: After one week with each type of mask
Mean mouth opening during sleep
Mean mouth opening during sleep between oronasal mask versus nasal mask
Time frame: After one week with each type of mask
Non-intentional leaks
Non-intentional leaks recorded by the NIV-device
Time frame: 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)
Time frame: After one week with each type of mask
Plan to share: No
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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University Hospital, Grenoble