Impact of Humidification on Sleep Quality During Home Non Invasive Ventilation

NCT03561974 | Completed

• 1 other identifier: IMHUNIV
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Protocol Summary:

• 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.

Conditions

Chronic Respiratory Failure With Hypercapnia

Outcome Measures

Primary Outcomes (1)

• 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)

  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

  Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.

• Nature of patient-ventilator asynchrony

  Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.

• Number of patient-ventilator asynchrony

  Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.

• Comfort with non invasive ventilation

  Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.

• Nasal obstruction

  Assessement will be performed at baseline and 2 month after initiation of non invasive ventilation with or without humidification.

Study Arms (2)

Humidification

EXPERIMENTAL

Device: Humidification

Control group without humidification

NO INTERVENTION

Interventions

Humidification DEVICE

Patients will benefit of humidification and warming of delivered gaz by non-invasive ventilation thanks humidification system.

Humidification

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Less than eighteen years old
• Pregnancy
• Psychiatric or cognitive disorders in wich consent is not possible

Sponsors & Collaborators

• ADIR Association: lead

Study Sites (1)

ADIR Association

Bois-Guillaume, 76230, France

Location

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2018
• First Posted: June 19, 2018
• Study Start: May 21, 2018
• Primary Completion: March 14, 2019
• Study Completion: March 14, 2019
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

FR (1)