The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea

NCT03156413 | Completed DMC

• 1 other identifier: CIA-206
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the mask.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Ease of use

  Subjective questionnaire

  1 night

• Acceptability

  Subjective questionnaire

  1 night

Secondary Outcomes (1)

• Objective leak data

  1 night

Study Arms (1)

F&P Nasal Mask

EXPERIMENTAL

Trial nasal pillows CPAP mask

Device: F&P nasal mask

Interventions

F&P nasal mask DEVICE

Investigative Nasal Mask to be used for OSA therapy

F&P Nasal Mask

Eligibility Criteria

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

You may qualify if:

• Adult (18+ years of age)
• Able to give consent
• Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
• Prescribed PAP for OSA
• Existing nasal mask user

You may not qualify if:

• Inability to give consent
• Patients who are in a coma or a decreased level of consciousness
• Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency
• Current diagnosis of carbon dioxide (CO2) retention
• Pregnant or may think they are pregnant

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Fisher and Paykel Healthcare

Auckland, 2013, New Zealand

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Sarah Gunson

  Sponsor Employee

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 17, 2017
• Study Start: May 29, 2017
• Primary Completion: June 5, 2017
• Study Completion: June 5, 2017
• Last Updated: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)