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

Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04391699
Acronym
Humidifier
Enrollment
0
Registered
2020-05-18
Start date
2018-04-30
Completion date
2019-07-31
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osa Syndrome

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.

Interventions

heated humidification system

Sponsors

DOM AIR
CollaboratorUNKNOWN
ResMed
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
CPAP mean usage (hours/night) at the 3 month follow up3 monthstherapy compliance

Secondary

MeasureTime frameDescription
Sleep quality3 monthspittsburgh sleep questionnaire index. total score
sleepiness3 monthsepworth sleep scale. total score

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026