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.
361 studies on the registry are indexed under Neuromuscular Diseases; 97 are open to participants now.
This study's enrollment of 30 is close to the median of 30 across 204 interventional studies indexed under Neuromuscular Diseases.
Browse Neuromuscular Diseases studies →University Hospital, Grenoble is the lead sponsor of 837 studies on the registry; 207 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from May 2018 to primary completion in Jun 2018, 1 month.
Of 75 non-industry interventional studies with no phase under Neuromuscular Diseases, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 47. This study's 1 month is below that.
Counting every sponsor, half of 84 studies reached it within 25 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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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