Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation
- Conditions
- Alveolar HypoventilationNeuromuscular Diseases
- Interventions
- Device: Switch of nocturnal NIV interface
- Registration Number
- NCT03458507
- Lead Sponsor
- University Hospital, Grenoble
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Usual interface Switch of nocturnal NIV interface 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. Alternative interface 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.
- Primary Outcome Measures
Name Time Method Mean nocturnal oxygen saturation (SpO2) After one week with each type of mask Mean nocturnal SpO2, measured by oximetry.
- Secondary Outcome Measures
Name Time Method Mean nocturnal PtcCO2 After one week with each type of mask Mean nocturnal transcutaneous partial pressure in CO2 (PtcCO2) evaluated by capnography between oronasal mask versus nasal mask
Non-intentional leaks After one week with each type of mask Non-intentional leaks recorded by the NIV-device
Mean mouth opening during sleep After one week with each type of mask Mean mouth opening during sleep between oronasal mask versus nasal mask
Side-effects of Continuous Positive Airway Pressure (CPAP) After one week with each type of mask 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)% sleep recording with SpO2<90% After one week with each type of mask Percentage of sleep recording spent with SpO2\<90% between oronasal mask versus nasal mask
Oxygen Desaturation Index After one week with each type of mask Oxygen desaturation index between oronasal mask versus nasal mask
Trial Locations
- Locations (1)
Grenoble-Alpes University hospital
🇫🇷Grenoble, France