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

• Sponsor: ResMed (Industry)
• Overall Status: Withdrawn
• CT.gov ID: NCT04391699
• Collaborator: DOM AIR (Other)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osa Syndrome	Device: heated humidification	N/A

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
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Humidifier Study: Evaluation of Prophylactic Heated Humidification on Obstructive Sleep Apnea (OSA) Patient Short Term Compliance to CPAP Therapy: Randomized Clinical Trial
• Anticipated Study Start Date: Apr 1, 2018
• Anticipated Primary Completion Date: Apr 1, 2019
• Anticipated Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPAP + Heated humidification CPAP + Heated humidification	Device: heated humidification; heated humidification system
No Intervention: CPAP alone CPAP

Outcome Measures

Primary Outcome Measures

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

   therapy compliance

Secondary Outcome Measures

1. Sleep quality [3 months]

   pittsburgh sleep questionnaire index. total score

2. sleepiness [3 months]

   epworth sleep scale. total score

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Bel Air	Bordeaux		France	33200

Sponsors and Collaborators

• ResMed
• DOM AIR

Investigators

• Principal Investigator: Nathalie Raymond, MD, clinique Bel Air

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ResMed
• ClinicalTrials.gov Identifier: NCT04391699
• Other Study ID Numbers: Humidifier 001
• First Posted: May 18, 2020
• Last Update Posted: May 18, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Apnea, Obstructive

Study Results

No Results Posted as of May 18, 2020