Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation (IMHUNIV)
Primary Purpose
Chronic Respiratory Failure With Hypercapnia
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Humidification
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Respiratory Failure With Hypercapnia
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.
Sites / Locations
- ADIR Association
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Humidification
Control group without humidification
Arm Description
Outcomes
Primary Outcome Measures
Change from baseline in sleep quality at two month
Sleep quality will be assessed by polysomnography without non invasive ventilation at Baseline versus with non invasive ventilation at follow up with or without humification (after 2month)
Secondary Outcome Measures
Subjective sleep quality
Outcome will be assessed using the Pittsburgh sleep quality index. The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The measure consists of nineteen individual items, creating seven components which are summed to produce a global score. Each component ranges from zero to three (zero: no difficulty at all ; three: great difficulties). Global score ranges from zero (no difficulty) to twenty-one points (great difficulties).
Nature of patient-ventilator asynchrony
Outcome will be assessed by two independent investigators through raw data from the ventilator
Number of patient-ventilator asynchrony
Outcome will be assessed by two independent investigators through raw data from the ventilator
Comfort with non invasive ventilation
Outcome will be assessed using a visual analogic scale ranging from zero to ten (zero: very uncomfortable ; ten: greater comfort).
Nasal obstruction
Outcome will be assessed using the Nasal Obstruction Symptom Evaluation questionary (NOSE) which is an instrument allowing clinicians to better understand impact of nasal obstruction on patients' quality of life. The measure consists of five individual items evaluated on a one-month past interval. Each item ranges from zero (not a problem) to four (severe problem). Then, scores are summed to create a global score ranging from zero (not a problem) to twenty (severe problem).
Rhinorrhea and xerostomia
Outcomes will be assessed using visual analogic scale ranging from zero to ten (zero: no rhinorrhea or xerostomia at all ; ten: worse rhinorrhea or xerostomia).
Quality of life: Severe Inspirator Insufficiency questionary
Outcome will be assessed using the Severe Inspirator Insufficiency questionary. It's a specific instrument for measuring health-related quality of life in patients receiving home mechanical ventilation. The measure consists of forty-nine individual items, creating seven components which are summed to produce a global score. Each item ranges from one to five (one: not true ; five: very true). Each component ranges from zero to one hundred. Global score is the seven components' mean. It ranges from zero (bad quality of life) to one hundred percent (best quality of life).
Number of nightime disruption of non invasive ventilation
Outcome will be assessed using raw data from the ventilator.
Adherence
Number of hours of treatment by night
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03561974
Brief Title
Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
Acronym
IMHUNIV
Official Title
Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
March 14, 2019 (Actual)
Study Completion Date
March 14, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ADIR Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Protocol Summary:
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Respiratory Failure With Hypercapnia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Humidification
Arm Type
Experimental
Arm Title
Control group without humidification
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Humidification
Intervention Description
Patients will benefit of humidification and warming of delivered gaz by non-invasive ventilation thanks humidification system.
Primary Outcome Measure Information:
Title
Change from baseline in sleep quality at two month
Description
Sleep quality will be assessed by polysomnography without non invasive ventilation at Baseline versus with non invasive ventilation at follow up with or without humification (after 2month)
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Secondary Outcome Measure Information:
Title
Subjective sleep quality
Description
Outcome will be assessed using the Pittsburgh sleep quality index. The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. The measure consists of nineteen individual items, creating seven components which are summed to produce a global score. Each component ranges from zero to three (zero: no difficulty at all ; three: great difficulties). Global score ranges from zero (no difficulty) to twenty-one points (great difficulties).
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Title
Nature of patient-ventilator asynchrony
Description
Outcome will be assessed by two independent investigators through raw data from the ventilator
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Title
Number of patient-ventilator asynchrony
Description
Outcome will be assessed by two independent investigators through raw data from the ventilator
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Title
Comfort with non invasive ventilation
Description
Outcome will be assessed using a visual analogic scale ranging from zero to ten (zero: very uncomfortable ; ten: greater comfort).
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Title
Nasal obstruction
Description
Outcome will be assessed using the Nasal Obstruction Symptom Evaluation questionary (NOSE) which is an instrument allowing clinicians to better understand impact of nasal obstruction on patients' quality of life. The measure consists of five individual items evaluated on a one-month past interval. Each item ranges from zero (not a problem) to four (severe problem). Then, scores are summed to create a global score ranging from zero (not a problem) to twenty (severe problem).
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Title
Rhinorrhea and xerostomia
Description
Outcomes will be assessed using visual analogic scale ranging from zero to ten (zero: no rhinorrhea or xerostomia at all ; ten: worse rhinorrhea or xerostomia).
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Title
Quality of life: Severe Inspirator Insufficiency questionary
Description
Outcome will be assessed using the Severe Inspirator Insufficiency questionary. It's a specific instrument for measuring health-related quality of life in patients receiving home mechanical ventilation. The measure consists of forty-nine individual items, creating seven components which are summed to produce a global score. Each item ranges from one to five (one: not true ; five: very true). Each component ranges from zero to one hundred. Global score is the seven components' mean. It ranges from zero (bad quality of life) to one hundred percent (best quality of life).
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Title
Number of nightime disruption of non invasive ventilation
Description
Outcome will be assessed using raw data from the ventilator.
Time Frame
Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Title
Adherence
Description
Number of hours of treatment by night
Time Frame
Outcome will be assessed at study completion (two months follow-up).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine Cuvelier, Prof, PhD
Organizational 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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maxime Patout, MD, MsC
Organizational 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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Astrid Bertier, MD
Organizational 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
Official's Role
Principal Investigator
Facility Information:
Facility Name
ADIR Association
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
12. IPD Sharing Statement
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Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
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