Back to resultsEvaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy (Humidifier)
Primary Purpose
Osa Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
heated humidification
Sponsored by
About this trial
This is an interventional treatment trial for Osa Syndrome
Eligibility 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)
Sites / Locations
- Clinique Bel Air
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
CPAP + Heated humidification
CPAP alone
Arm Description
CPAP + Heated humidification
CPAP
Outcomes
Primary Outcome Measures
CPAP mean usage (hours/night) at the 3 month follow up
therapy compliance
Secondary Outcome Measures
Sleep quality
pittsburgh sleep questionnaire index. total score
sleepiness
epworth sleep scale. total score
Full Information
NCT ID
NCT04391699
First Posted
January 29, 2018
Last Updated
May 13, 2020
Sponsor
ResMed
Collaborators
DOM AIR
1. Study Identification
Unique Protocol Identification Number
NCT04391699
Brief Title
Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy
Acronym
Humidifier
Official Title
Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Withdrawn
Why Stopped
cancelled before initiation
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
July 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ResMed
Collaborators
DOM AIR
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
To compare two different clinical strategies in order to evaluate the impact of prophylactic heated humidification on OSA patients' compliance to CPAP therapy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osa Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CPAP + Heated humidification
Arm Type
Experimental
Arm Description
CPAP + Heated humidification
Arm Title
CPAP alone
Arm Type
No Intervention
Arm Description
CPAP
Intervention Type
Device
Intervention Name(s)
heated humidification
Intervention Description
heated humidification system
Primary Outcome Measure Information:
Title
CPAP mean usage (hours/night) at the 3 month follow up
Description
therapy compliance
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Sleep quality
Description
pittsburgh sleep questionnaire index. total score
Time Frame
3 months
Title
sleepiness
Description
epworth sleep scale. total score
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathalie Raymond, MD
Organizational Affiliation
clinique Bel Air
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique Bel Air
City
Bordeaux
ZIP/Postal Code
33200
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy
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