Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: New nasal pillows mask with PAP therapy

• Registration Number: NCT04063436
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-08-13
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Study Start: 2019-09-23
• Primary Completion: 2019-10-11
• Study Completion: 2019-10-11
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-19
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Are ≥22 years of age
• Weigh ≥66 lbs
• Have been formally diagnosed with OSA by a physician
• Have an AHI ≥5 on a diagnostic night
• Have been prescribed PAP therapy to treat OSA by a physician
• Are an existing nasal pillows mask user
• Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
• Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
• Are fluent in spoken and written English
• Possess the capacity to provide informed consent

Exclusion Criteria

• Are intolerant to PAP therapy
• Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
• Are currently diagnosed with respiratory disease or CO2 retention
• Are pregnant or think they may be pregnant
• Have an IPAP pressure of >25 cmH2O
• Persons who use a PAP therapy machine for the delivery of medicines, except O2
• Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	New nasal pillows mask with PAP therapy	Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.

Primary Outcome Measures

Name	Time	Method
Performance of new nasal pillows mask	14±5 days	The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines.

Secondary Outcome Measures

Name	Time	Method
Comfort of new nasal pillows mask	14±5 days	The new nasal pillows mask is comfortable during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.
Usability of new nasal pillows mask	14±5 days	The new nasal pillows mask is user-friendly during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.

Trial Locations

Locations (1)

Ohio Sleep Medicine Institute; 🇺🇸 Dublin, Ohio, United States