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NCT Number: NCT03458507

Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation

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.

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Key information

Conditions

Neuromuscular Diseases Alveolar Hypoventilation Hypoventilation Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grenoble-Alpes University hospital

Grenoble, 38000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Switch of nocturnal NIV interface

Device
  • 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.
  • Interface switch
  • 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.

Primary outcomes

  1. Mean nocturnal oxygen saturation (SpO2)

    Time frame: After one week with each type of mask

    Mean nocturnal SpO2, measured by oximetry.

Secondary outcomes

  1. % sleep recording with SpO2<90%

    Time frame: After one week with each type of mask

    Percentage of sleep recording spent with SpO2<90% between oronasal mask versus nasal mask

  2. Oxygen Desaturation Index

    Time frame: After one week with each type of mask

    Oxygen desaturation index between oronasal mask versus nasal mask

  3. Mean nocturnal PtcCO2

    Time frame: 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

  4. Mean mouth opening during sleep

    Time frame: After one week with each type of mask

    Mean mouth opening during sleep between oronasal mask versus nasal mask

  5. Non-intentional leaks

    Time frame: After one week with each type of mask

    Non-intentional leaks recorded by the NIV-device

  6. Side-effects of Continuous Positive Airway Pressure (CPAP)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Association Française contre les Myopathies (AFM), Paris
  • Hôpital Raymond Poincaré

Registry information

Official study title

Impact of the Type of Interface in Neuromuscular Patients Treated With Nocturnal Noninvasive Ventilation: a Randomized Crossover Trial

Acronym: InterfaceNMD

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Mar 8, 2018
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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