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Completed

NCT Number: NCT03413098

The Evaluation of a Novel Nasal Mask for the Treatment of Obstructive Sleep Apnea

This investigation is a prospective, non randomized, non blinded study. This investigation is designed to evaluate the performance, comfort and ease of use with the F&P trial nasal mask amongst Obstructive Sleep Apnea (OSA) patients.

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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

Hastings Memorial Hospital, Hastings, New Zealand

Loading trial locations.

About this study

Visit 1 will involve the participants consented in to the trial. Visit 2 will involve the participants being fitted with the F&P trial nasal mask for use in-home.

The participant will then come in to return the mask (Visit Three) and have a final interview, this ensures the maximum time participants will be exposed to the trial mask in home will be 14 ± 4 days from visit two.

The mask will be returned to the Institution at the conclusion of the trial and the participant will return to their previous mask. The Institution will recruit all patients within 1 week of the beginning of the study.

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 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

Nasal CPAP mask

Device

Investigative Nasal Mask to be used for OSA therapy

Primary outcomes

  1. Ease of use

    Time frame: 2 weeks

    Subjective Questionnaire

  2. Acceptability

    Time frame: 2 weeks

    Subjective Questionnaire

Secondary outcomes

  1. Objective leak data

    Time frame: 2 weeks

    Data obtained from participant's device - Objective

Sponsors and collaborators

Lead sponsor

Fisher and Paykel Healthcare

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2018
Registry last updated
Mar 22, 2018

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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