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OpenTrials
Completed

NCT Number: NCT02541214

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

Currently, Fisher and Paykel Healthcare (FPH) is developing a new nasal mask.

This investigation is designed to evaluate the performance of the trial nasal mask, focused specifically on how the different seal sizes will perform on Obstructive Sleep Apnea participants who are currently on Positive Airway Pressure therapy.

Participant's prescribed treatment pressure with their usual mask will be collected for 7 days ± 3 days prior to mask fitting with the trial nasal mask. They will then be issued with the trial nasal mask to use in-home for 14 days ± 4 days.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Waikato District Health Board, Hamilton, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18+
  • Diagnosed with Ostructive Sleep Apnea by a practicing physician or clinicans
  • Existing nasal or nasal pillows user
  • Prescribed Positive Airway Pressure therapy (Bi-Level or Continuous Positive Airway Pressure (CPAP) or Automatic Positive Airway Pressure (APAP))

Exclusion criteria

  • Inability to give informed consent
  • Pregnant or think they may be pregnant
  • Anatomical or physiological conditions making Positive Airway Pressure therapy inappropriate (e.g unconsolidated facial fracture)
  • Patients who are in a coma or decreased level of consciousness
  • Current diagnosis of CO2 retention
  • Commercial Drivers who are investigated by New Zealand Transport Agency (NZTA)

Treatment and study plan

Trial Nasal Mask

Device

Primary outcomes

  1. Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire

    Time frame: 2 weeks in home

Secondary outcomes

  1. Seal performance of the trial Nasal mask as measured by the subjective perception of leak through a custom questionnaire, in addition to objective leak data and treatment efficacy through the Positive Airway Pressure therapy device.

    Time frame: 2 weeks in home

    the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"

  2. Objective leak data through the Positive Airway Pressure therapy device

    Time frame: 2 weeks in home

    Evaluating the leak of the trial Nasal mask

  3. Treatment efficacy through the Positive Airway Pressure therapy device

    Time frame: 2 weeks in home

    Evaluating the number of apnea/hypopnea per hour

  4. Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.

    Time frame: 2 weeks in home

    the participant would either choose the trial Nasal mask or their usual mask as their primary mask

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 4, 2015
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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