Chronic Respiratory Failure With HypercapniaIMHUNIVNCT03561974
Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
A study testing Humidification in people with Chronic Respiratory Failure With Hypercapnia, run by ADIR Association at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Failure With Hypercapnia
- What is being tested?
- Humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2018to 14 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Less than eighteen years old
- Pregnancy
- Psychiatric or cognitive disorders in wich consent is not possible
- Acute respiratory failure within 2 weeks before inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
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
Read more
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.
- Being tested
- Humidification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HumidificationDevice
Patients will benefit of humidification and warming of delivered gaz by non-invasive ventilation thanks humidification system.
| Study group | Role | What they receive |
|---|---|---|
| Humidification | Experimental | Not described Receives: Device: Humidification |
| Control group without humidification | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Secondary outcomes (9)
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).
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Nature of patient-ventilator asynchrony
Outcome will be assessed by two independent investigators through raw data from the ventilator
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Number of patient-ventilator asynchrony
Outcome will be assessed by two independent investigators through raw data from the ventilator
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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).
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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).
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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).
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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).
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Number of nightime disruption of non invasive ventilation
Outcome will be assessed using raw data from the ventilator.
Measured: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Adherence
Number of hours of treatment by night
Measured: Outcome will be assessed at study completion (two months follow-up).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start21 May 2018
- Primary completion14 Mar 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Respiratory Failure With HypercapniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ADIR Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Cuvelier, Prof, PhD, Principal investigator, 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, FranceMaxime Patout, MD, MsC, Principal investigator, 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, FranceAstrid Bertier, MD, Principal investigator, 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561974
- Sponsor's protocol ID
- IMHUNIV
- Acronym
- IMHUNIV
- Status last verified
- Mar 2019
- First submitted
- 18 May 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation
- ClinicalTrials.gov ID
- NCT03561974
- Acronym / sponsor ID
- IMHUNIV / IMHUNIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ADIR AssociationUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 14 Mar 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 19 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Humidification | Experimental | Device: Humidification |
| Control group without humidification | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Less than eighteen years old
- Pregnancy
- Psychiatric or cognitive disorders in wich consent is not possible
- Acute respiratory failure within 2 weeks before inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HumidificationPatients will benefit of humidification and warming of delivered gaz by non-invasive ventilation thanks humidification system. | Device | Humidification |
Primary outcome
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)
9 secondary outcomes
Subjective sleep quality
Time frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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.
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.
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.
Nasal obstruction
Time frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
Rhinorrhea and xerostomia
Time frame: Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.
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.
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.
Adherence
Time frame: Outcome will be assessed at study completion (two months follow-up).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine Cuvelier, Prof, PhD principal investigator
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
Maxime Patout, MD, MsC principal investigator
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
Astrid Bertier, MD principal investigator
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Humidification in people with Chronic Respiratory Failure With Hypercapnia, run by ADIR Association at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.