NCT04391699

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
11 months until next milestone

First Posted

Study publicly available on registry

May 18, 2020

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

1 year

First QC Date

January 29, 2018

Last Update Submit

May 13, 2020

Conditions

Osa Syndrome

Outcome Measures

Primary Outcomes (1)

  • CPAP mean usage (hours/night) at the 3 month follow up

    therapy compliance

    3 months

Secondary Outcomes (2)

  • Sleep quality

    3 months

  • sleepiness

    3 months

Study Arms (2)

CPAP + Heated humidification

EXPERIMENTAL

CPAP + Heated humidification

Device: heated humidification

CPAP alone

NO INTERVENTION

CPAP

Interventions

heated humidificationDEVICE

heated humidification system

CPAP + Heated humidification

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Bel Air

Bordeaux, 33200, France

Location

MeSH Terms

Conditions

Carnevale syndrome

Study Officials

  • Nathalie Raymond, MD

    clinique Bel Air

    PRINCIPAL INVESTIGATOR
0

Study Design

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

Study Record Dates

First Submitted

January 29, 2018

First Posted

May 18, 2020

Study Start

April 1, 2018

Primary Completion

April 1, 2019

Study Completion

July 1, 2019

Last Updated

May 18, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)