Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

NCT02297789 | Completed DMC

• 1 other identifier: CIA-152
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

Currently Fisher \& Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear. The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• The mask is comfortable and is effective for the participant during in-home use

  Performance in relations to leak and comfort of each prototype and how it compares to their usual mask, as measured by a custom questionnaire, daily participant feedback log and PAP device data.

  1 week for each mask prototype in-home

Secondary Outcomes (1)

• Acceptability of the Full Face mask prototypes

  1 week for each mask prototype in-home

Study Arms (2)

Headgear 1

EXPERIMENTAL

Full Face Mask with Headgear 1

Device: Investigative Full Face Mask with Headgear

Headgear 2

EXPERIMENTAL

Full Face Mask with Headgear 2

Device: Investigative Full Face Mask with Headgear

Interventions

Investigative Full Face Mask with Headgear DEVICE

Headgear 1; Headgear 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AHI ≥ 5 from the diagnostic night
• ≥ 18 years of age
• Either prescribed APAP or CPAP or Bi level for OSA
• Existing full face users

You may not qualify if:

• Inability to give informed consent
• Participant intolerance to PAP
• Anatomical or physiological conditions making PAP therapy inappropriate
• Current diagnosis of respiratory disease or CO2 retention
• Pregnant or think they may be pregnant

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Fisher & Paykel Healthcare Ltd.

Auckland, East Tamaki, 1010, New Zealand

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 Officials

• Bhavi Ogra, BSc

  Fisher & Paykel Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 21, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

NZ (1)