NCT04391699WithdrawnNot Applicable
Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial
ResMed1 site in 1 countryStarted: April 1, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Locations
- 1
- Primary Endpoint
- CPAP mean usage (hours/night) at the 3 month follow up
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
CPAP + Heated humidification
Experimental
CPAP + Heated humidification
Intervention: heated humidification (Device)
CPAP alone
No Intervention
CPAP
Outcomes
Primary Outcomes
CPAP mean usage (hours/night) at the 3 month follow up
Time Frame: 3 months
therapy compliance
Secondary Outcomes
- Sleep quality(3 months)
- sleepiness(3 months)
Investigators
Study Sites (1)
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