Clinical trial NCT03561974: Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
Official title: Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Respiratory Failure With Hypercapnia
Lead sponsor: ADIR Association
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Protocol Summary:

1. Question Does the adjunction of a humidification system to non-invasive ventilation circuit improve sleep quality and comfort of chronic ventilated respiratory insufficient patients? Does it change the efficacy of long-term non invasive ventilation therapy and patient-ventilator interactions?
2. Aims

Main aim:

The primary endpoint of this study is to objectively evaluate the consequences of a humidification system's adjunction on quality of sleep, 2 months after treatment's beginning.

Second aims:

The secondary endpoints are to evaluate the consequences of a humidification system's adjunction on non invasive ventilation's efficacy / patient-ventilator asynchronies / patients' comfort / treatment adherence.

Before the clinical trial, the investigators conducted a bench study using a mechanical lung in order to evaluate the ventilator's behavior with and without a humidification system.

The clinical trial will include patients with chronic respiratory failure with an indication of long-term non invasive ventilation therapy. Patients will be included in the Pulmonology, Thoracic Oncology and Respiratory intensive care unit of Rouen University Hospital.

It will be a prospective monocentric study, including consecutively all eligible patients. Informed consent will be obtained from all of them.

At baseline, patients will be hospitalized for two consecutive nights for non invasive ventilation's set up. During the first night, a polysomnography will be performed without non invasive ventilation. Then, patients will be treated by non invasive ventilation with a bi-level self-regulated pressure mode and an open circuit.

Patients will be randomized in two groups: without a humidification system and with a humidification system. Partitioning by the physiopathological pattern (obstructive versus obesity hypoventilation syndrome vs. neuromuscular disease) will be done.

During each night, arterial blood gases will be measured at bedtime and awakening. Patients will be monitored by:

* polysomnography (only during the first night)
* transcutaneous capnography
* accessory inspiratory muscles surface electromyography
* pneumotachograph on non invasive ventilation's circuit
* pressions measured at the mask.

Follow-up will take place at two months after non invasive ventilation's beginning with or without humidification. Patients will be hospitalized for one night only. Blood gases at bedtime and at awakening will be measured. A polysomnography with non invasive ventilation will be performed. Observance will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Type 2 chronic respiratory failure (PaCO2 \> 6,5 at the time of the diagnosis)
* Indication of a long term non invasive ventilation at home because of an obstructive respiratory disease, a obesity hypoventilation syndrome or a neuromuscular disease.
* Over eighteen years old
* Planned hospitalisation to introduce non invasive ventilation.

Exclusion Criteria:

* Less than eighteen years old
* Pregnancy
* Psychiatric or cognitive disorders in wich consent is not possible
* Acute respiratory failure within 2 weeks before inclusion.

Primary outcomes:
measure: Change from baseline in sleep quality at two month
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Secondary outcomes:
measure: Subjective sleep quality
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
measure: Nature of patient-ventilator asynchrony
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
measure: Number of patient-ventilator asynchrony
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
measure: Comfort with non invasive ventilation
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
measure: Nasal obstruction
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
measure: Rhinorrhea and xerostomia
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
measure: Quality of life: Severe Inspirator Insufficiency questionary
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
measure: Number of nightime disruption of non invasive ventilation
timeFrame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
measure: Adherence
timeFrame: Outcome will be assessed at study completion (two months follow-up).
Other outcomes:
Locations:
city: Bois-Guillaume
country: France
facility: ADIR Association
Study officials:
affiliation: CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
name: Antoine Cuvelier, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
name: Maxime Patout, MD, MsC
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU-Hôpitaux de Rouen - Service de pneumologie, Hôpital de Bois-Guillaume, Rouen, France ; UPRES EA 3830, Institut de Recherche et d'Innovation Biomédicale de Haute-Normandie, Université de Rouen, Rouen, France
name: Astrid Bertier, MD
role: PRINCIPAL_INVESTIGATOR
References: