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

NCT02730273 | Completed DMC

• 1 other identifier: CIA-184
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This investigation is designed to evaluate the performance (leak and comfort) as well as the participant's overall acceptance of the trial nasal mask amongst Obstructive Sleep Apnea (OSA) participants. An important factor in this investigation will be the testing of two different seal sizes on the participants (medium and large size). A total number of 12 participants who currently use nasal or nasal pillow masks will be recruited for the trial. Participants have been selected based on their anthropometric measurements collected in previous trials (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited from the Fisher \& Paykel Healthcare Database of subjects with OSA (Ethics Reference NTY/08/06/064), Auckland District Health Board (ADHB) and New Zealand Respiratory and Sleep Institute (NZRSI). Participants will use the trial mask in home for a period of 7 ± 3 days and also 1 overnight polysomnography session at the Fisher \& Paykel Healthcare sleep lab. Baseline data will be collected from the participant during the first visit, 7 days of CPAP usage data will be downloaded and stored for analysis. The participant will use the trial device on their usual Continuous or Auto Positive Airway Pressure (CPAP/APAP) setting and device for the duration of the trial.

Conditions

Sleep Disordered Breathing; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (7)

• Objective leak data (L/min)

  Obtained from the participant's device

  Up to 1 week in-home

• Subjective measurement of leak

  Subjective Questionnaire

  Up to 1 week in-home

• Comfort

  Subjective Questionnaire

  Up to 1 week in-home

• Stability

  Subjective Questionnaire

  Up to 1 week in-home

• Draft

  Subjective Questionnaire

  Up to 1 week in-home

• Noise

  Subjective Questionnaire

  Up to 1 week in-home

• Objective leak data (L/min)

  Obtained from the overnight polysomnography

  1 night

Secondary Outcomes (1)

• Preference of the mask

  Up to 1 week in-home

Study Arms (1)

Trial Nasal Mask

EXPERIMENTAL

Participants to use nasal mask in-home for a week and one night in lab overnight polysomnography.

Device: Trial Nasal mask

Interventions

Trial Nasal mask DEVICE

Nasal mask for the treatment of obstructive sleep apnea (OSA)

Trial 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 a Continuous Positive Airway Pressure (CPAP) device after successful OSA diagnosis
• Existing nasal or nasal pillow 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 APAP therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency (NZTA)
• Current diagnosis of CO2 retention
• Pregnant or may think they are pregnant.

Sponsors & Collaborators

• Fisher and Paykel Healthcare: lead

Study Sites (1)

Fisher & 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

• 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: March 13, 2016
• First Posted: April 6, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2016
• Study Completion: April 1, 2016
• Last Updated: July 17, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)