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

NCT04063436 | Withdrawn DMC FDA Device

• 1 other identifier: CIA-264
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Performance of new nasal pillows mask

  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.

  14±5 days

Secondary Outcomes (2)

• Comfort of new nasal pillows mask

  14±5 days

• Usability of new nasal pillows mask

  14±5 days

Study Arms (1)

Experimental

EXPERIMENTAL

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.

Device: New nasal pillows mask with PAP therapy

Interventions

New nasal pillows mask with PAP therapy DEVICE

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.

Experimental

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Ohio Sleep Medicine Institute

Dublin, Ohio, 43017, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: After the baseline period, all participants will be trialed on the same new nasal pillows mask.

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 21, 2019
• Study Start: September 23, 2019
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)