An Investigation to Test a Prototype Full-face Mask in the Home Setting

NCT02938208 | Completed DMC

• 1 other identifier: CIA-198
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

This investigation is a prospective non-blinded and non-randomized clinical investigation. This investigation is designed to evaluate the performance (leak and comfort) as well as participant's overall acceptance of the Jupiter mask amongst OSA participants. A total number of up to 15 OSA participants who currently use full face masks will be recruited for the trial.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (6)

• Objective mask leak data measurement (System Leak)

  Obtained from participant's CPAP device, measured in L/min

  Up to 21 ± 6 days in-home

• Subjective Measurement of leak assessed using a Subjective Questionnaire

  Subjective Questionnaire

  Up to 21 ± 6 days in-home

• Comfort assessed using a Subjective Questionnaire

  Subjective Questionnaire

  Up to 21 ± 6 days in-home

• Stability assessed using a Subjective Questionnaire

  Subjective Questionnaire

  Up to 21 ± 6 days in-home

• Draft assessed using a Subjective Questionnaire

  Subjective Questionnaire

  Up to 21 ± 6 days in-home

• Noise assessed using a Subjective Questionnaire

  Subjective Questionnaire

  Up to 21 ± 6 days in-home

Secondary Outcomes (2)

• Preference of Mask assessed using a Subjective Questionnaire

  Up to 21 ± 6 days in-home

• Usability via mask unboxing/fitting exercise with a subjective questionnaire

  Up to 21 ± 6 days in-home

Study Arms (1)

Jupiter Full Face Mask

EXPERIMENTAL

Participants to use full face mask in-home for a 14 ± 3 days in-home.

Device: Jupiter Full Face Mask

Interventions

Jupiter Full Face Mask DEVICE

Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.

Jupiter Full Face Mask

Eligibility Criteria

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

You may qualify if:

• + years of age
• Diagnosed with OSA by a practicing physician
• Prescribed PAP therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP)). Patient can be naïve to CPAP therapy or experienced (6 months and more)
• Existing full face mask users
• Patients who are able to put on and remove their current mask without gross difficulty relating to an existing condition (e.g. arthritis of the hands).

You may not qualify if:

• Inability to give informed consent
• Anatomical or physiological conditions making PAP therapy inappropriate (e.g unconsolidated facial fracture)
• Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)
• Current diagnosis of CO2 retention
• Pregnant or think they may be pregnant

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (2)

Fisher & Paykel Healthcare

Auckland, 2013, New Zealand

Location

Wellsleep: Bowen Hospital

Wellington, 6035, 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

• Kayan Gonda, BSc

  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: October 16, 2016
• First Posted: October 19, 2016
• Study Start: November 3, 2016
• Primary Completion: November 21, 2016
• Study Completion: May 31, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)