Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation: a Randomized Crossover Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neuromuscular Diseases
- Sponsor
- University Hospital, Grenoble
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean nocturnal oxygen saturation (SpO2)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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:
- the application of oronasal mask may jeopardize the pharyngeal patency in patients already proned to upper airway obstruction;
- 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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Mean nocturnal oxygen saturation (SpO2)
Time Frame: After one week with each type of mask
Mean nocturnal SpO2, measured by oximetry.
Secondary Outcomes
- Mean nocturnal PtcCO2(After one week with each type of mask)
- Non-intentional leaks(After one week with each type of mask)
- Mean mouth opening during sleep(After one week with each type of mask)
- Side-effects of Continuous Positive Airway Pressure (CPAP)(After one week with each type of mask)
- % sleep recording with SpO2<90%(After one week with each type of mask)
- Oxygen Desaturation Index(After one week with each type of mask)