Osa SyndromeHumidifierNCT04391699
Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy
A study testing heated humidification in people with Osa Syndrome, run by ResMed at 1 site in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osa Syndrome
- What is being tested?
- heated humidification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2018to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patient
- Newly diagnosed OSA Patients eligible to CPAP therapy
- Signed informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial
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.
- Conditions
- Osa Syndrome
- Being tested
- heated humidification
- Medical subject headings
- Carnevale syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heated humidificationDevice
heated humidification system
| Study group | Role | What they receive |
|---|---|---|
| CPAP + Heated humidification | Experimental | CPAP + Heated humidification Receives: Device: heated humidification |
| CPAP alone | No intervention | CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
CPAP mean usage (hours/night) at the 3 month follow up
therapy compliance
Measured: 3 months
Secondary outcomes (2)
Sleep quality
pittsburgh sleep questionnaire index. total score
Measured: 3 months
sleepiness
epworth sleep scale. total score
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionJul 2019 (estimated)
Why it stopped: cancelled before initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osa SyndromeStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- DOM AIR
- Responsible party
- Sponsor
- Investigators
- Nathalie Raymond, MD, Principal investigator, clinique Bel Air
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391699
- Sponsor's protocol ID
- Humidifier 001
- Acronym
- Humidifier
- Status last verified
- May 2020
- First submitted
- 29 Jan 2018
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04391699
- Acronym / sponsor ID
- Humidifier / Humidifier 001
- Conditions
- Osa Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: cancelled before initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- DOM AIR
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CPAP + Heated humidification | Experimental | Device: heated humidificationCPAP + Heated humidification |
| CPAP alone | No intervention | –CPAP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Patient
- Newly diagnosed OSA Patients eligible to CPAP therapy
- Signed informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heated humidificationheated humidification system | Device | CPAP + Heated humidification |
Primary outcome
CPAP mean usage (hours/night) at the 3 month follow up
Time frame: 3 months
therapy compliance
2 secondary outcomes
Sleep quality
Time frame: 3 months
sleepiness
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Individual participant dataSharing planned: No
Related trials for Osa Syndrome
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathalie Raymond, MD principal investigator
clinique Bel Air
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heated humidification in people with Osa Syndrome, run by ResMed at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CPAP mean usage (hours/night) at the 3 month follow up (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.