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WithdrawnNCT04391699HumidifierUpdated May 18, 2020

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

An interventional study of heated humidification in Osa Syndrome, sponsored by ResMed. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-18.

Sponsored by ResMed · Not applicable, Interventional, and Treatment

Why this study was withdrawn
cancelled before initiation
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Osa Syndrome
03

In context

Sleep Apnea, Obstructive

2,198 studies on the registry are indexed under Sleep Apnea, Obstructive; 469 are open to participants now.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

ResMed is the lead sponsor of 105 studies on the registry; 13 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 6 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    CPAP + Heated humidification

    CPAP + Heated humidification

    Device: heated humidification

  • No intervention
    CPAP alone

    CPAP

Interventions

  • Deviceheated humidification

    heated humidification system

06

What researchers measure

Primary outcomes

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

    therapy compliance

    Time frame: 3 months

Secondary outcomes

  1. Sleep quality

    pittsburgh sleep questionnaire index. total score

    Time frame: 3 months

  2. sleepiness

    epworth sleep scale. total score

    Time frame: 3 months

07

Study locations

1 site
  • Clinique Bel Air
    Bordeaux, 33200, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04391699
Lead sponsor
ResMed
Collaborators
DOM AIR
Responsible party
Sponsor
First posted
May 18, 2020
Start date
Apr 2018 (estimated)
Primary completion
Apr 2019 (estimated)
Completion
Jul 2019 (estimated)
Last update
May 18, 2020

Study contacts

Nathalie Raymond, MD
principal investigator · clinique Bel Air

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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