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OpenTrials
Completed

NCT Number: NCT03092921

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

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

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Key information

Conditions

Sleep Disordered Breathing Apnea Dyssomnias Nervous System Diseases Obstructive Sleep Apnea 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

Fisher & Paykel Healthcare

Auckland, 2013, New Zealand

About this study

A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.

An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

F&P Mask Seal

Device

Investigative Mask Seal to be used for OSA therapy

F&P Mask

Device

Investigative Mask to be used for OSA therapy

Primary outcomes

  1. Ease of use

    Time frame: 1 week in home

    Subjective questionnaire

  2. Acceptability

    Time frame: 1 week in home

    Subjective questionnaire

  3. Ease of use

    Time frame: 2 weeks in home

    Subjective questionnaire

  4. Acceptability

    Time frame: 2 weeks in home

    Subjective questionnaire

Secondary outcomes

  1. Objective leak data

    Time frame: 1 week in home

    Obtained from participants' device

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 28, 2017
Registry last updated
Aug 8, 2017

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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