Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation (IMHUNIV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03561974
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
ADIR Association

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.


Condition or disease Intervention/treatment Phase
Chronic Respiratory Failure With Hypercapnia Device: Humidification Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
Actual Study Start Date : May 21, 2018
Actual Primary Completion Date : March 14, 2019
Actual Study Completion Date : March 14, 2019

Arm Intervention/treatment
Experimental: Humidification Device: Humidification
Patients will benefit of humidification and warming of delivered gaz by non-invasive ventilation thanks humidification system.

No Intervention: Control group without humidification



Primary Outcome Measures :
  1. Change from baseline in sleep quality at two month [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    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 :
  1. Subjective sleep quality [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    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).

  2. Nature of patient-ventilator asynchrony [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    Outcome will be assessed by two independent investigators through raw data from the ventilator

  3. Number of patient-ventilator asynchrony [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    Outcome will be assessed by two independent investigators through raw data from the ventilator

  4. Comfort with non invasive ventilation [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    Outcome will be assessed using a visual analogic scale ranging from zero to ten (zero: very uncomfortable ; ten: greater comfort).

  5. Nasal obstruction [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    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).

  6. Rhinorrhea and xerostomia [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    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).

  7. Quality of life: Severe Inspirator Insufficiency questionary [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    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).

  8. Number of nightime disruption of non invasive ventilation [ Time Frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification. ]
    Outcome will be assessed using raw data from the ventilator.

  9. Adherence [ Time Frame: Outcome will be assessed at study completion (two months follow-up). ]
    Number of hours of treatment by night



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561974


Locations
Layout table for location information
France
ADIR Association
Bois-Guillaume, France, 76230
Sponsors and Collaborators
ADIR Association
Investigators
Layout table for investigator information
Principal Investigator: Antoine Cuvelier, Prof, PhD 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
Principal Investigator: Maxime Patout, MD, MsC 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
Principal Investigator: Astrid Bertier, MD 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
Layout table for additonal information
Responsible Party: ADIR Association
ClinicalTrials.gov Identifier: NCT03561974    
Other Study ID Numbers: IMHUNIV
First Posted: June 19, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Insufficiency
Hypercapnia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory