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

Osa Syndrome Clinical Trial

— Humidifier  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04391699
• Other study ID #: Humidifier 001
• Status: Withdrawn
• Phase: N/A
• Start date: April 2018
• Est. completion date: July 2019

Study information

• Verified date: May 2020
• Source: ResMed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osa Syndrome
• Sleep Apnea, Obstructive

Intervention

Device:
• heated humidification
heated humidification system

Locations

Country	Name	City	State
France	Clinique Bel Air	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
ResMed	DOM AIR

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CPAP mean usage (hours/night) at the 3 month follow up	therapy compliance	3 months
Secondary	Sleep quality	pittsburgh sleep questionnaire index. total score	3 months
Secondary	sleepiness	epworth sleep scale. total score	3 months