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Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy (Humidifier)

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: NCT04391699
Recruitment Status : Withdrawn (cancelled before initiation)
First Posted : May 18, 2020
Last Update Posted : May 18, 2020
Sponsor:
Collaborator:
DOM AIR
Information provided by (Responsible Party):
ResMed

Brief Summary:
To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

Condition or disease Intervention/treatment Phase
Osa Syndrome Device: heated humidification Not Applicable

Detailed Description:
To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: CPAP + Heated humidification
CPAP + Heated humidification
Device: heated humidification
heated humidification system

No Intervention: CPAP alone
CPAP



Primary Outcome Measures :
  1. CPAP mean usage (hours/night) at the 3 month follow up [ Time Frame: 3 months ]
    therapy compliance


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 3 months ]
    pittsburgh sleep questionnaire index. total score

  2. sleepiness [ Time Frame: 3 months ]
    epworth sleep scale. total score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult Patient
  • Newly diagnosed OSA Patients eligible to CPAP therapy
  • Signed informed consent

Exclusion Criteria:

  • CPAP therapy contraindications
  • Pregnancy
  • Patient unable to come to study follow up visits or unable to finish the study.
  • Informed consent not signed
  • Adults who are subject to a legal protection measure or are unable to express their consent (such as patients under guardianship and patients deprived of judicial or administrative freedom)

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): NCT04391699


Locations
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France
Clinique Bel Air
Bordeaux, France, 33200
Sponsors and Collaborators
ResMed
DOM AIR
Investigators
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Principal Investigator: Nathalie Raymond, MD clinique Bel Air
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Responsible Party: ResMed
ClinicalTrials.gov Identifier: NCT04391699    
Other Study ID Numbers: Humidifier 001
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases