Evaluation of Prophylactic Heated Humidification on Obstr... | NCT04391699

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

NCT04391699

Sponsor

ResMed

Status

Withdrawn

Last Update Posted

May 18, 2020Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Osa Syndrome

Interventions

heated humidification

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

cancelled before initiation

Expanded Access Info

Start Date

Apr 2018Estimated

Primary Completion Date

Apr 2019Estimated

Completion Date

Jul 2019Estimated

First Submitted Date

Jan 29, 2018

First Submission Date that Met QC Criteria

May 13, 2020

First Posted Date

May 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 13, 2020

Last Update Posted Date

May 18, 2020Actual

Name	Class
DOM AIR	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPAP + Heated humidification	Experimental	CPAP + Heated humidification	Device: heated humidification
CPAP alone	No Intervention	CPAP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
heated humidification	Device	heated humidification system	CPAP + Heated humidification

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
CPAP mean usage (hours/night) at the 3 month follow up	therapy compliance	3 months

Secondary Outcomes

Measure	Description	Time Frame
Sleep quality	pittsburgh sleep questionnaire index. total score	3 months
sleepiness	epworth sleep scale. total score	3 months

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nathalie Raymond, MD	clinique Bel Air	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinique Bel Air		Bordeaux		33200	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
C535586	Carnevale syndrome

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided