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The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial

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ClinicalTrials.gov Identifier: NCT03075722
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : April 20, 2017
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:

This investigation is designed to evaluate the performance (treatment and leak), comfort (subjective feedback), stability (subjective feedback, leak) as well as the participant's overall acceptance of the Saturn mask amongst OSA participants. An important factor in this investigation will be the testing of our two different seal sizes on the participants (small and medium size). A total number of 15 participants who currently use nasal or nasal pillow masks will be recruited for the trial. A subset of participants have been selected based on their anthropometric measurements collected in previous trials using nasal and nasal pillow masks at this site (CIA-103). Participants from previous NZ trials may be recruited into this trial with their consent. All the participants will be recruited by WellSleep, Wellington.

Participants will use the trial mask in home for a period of 7 ± 3 days. Baseline data will be collected from the participant during the first visit, the prior 7 days of CPAP usage data will be downloaded and stored for our analysis. The participant will use the trial device on their usual CPAP/APAP setting and device for the duration of the trial.

This study will be conducted in accordance with ICH/GCP guidelines. No deviation from the protocol will be implemented without prior review and approval of the sponsor except where it may be necessary to eliminate an immediate hazard to a research participant. In such case, the deviation will be reported to the sponsor as soon as possible.


Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Obstructive Sleep Apnea Device: Saturn nasal mask Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of a Nasal Mask for the Treatment of Obstructive Sleep Apnea (OSA): Comfort & Performance Trial
Actual Study Start Date : March 9, 2017
Actual Primary Completion Date : March 30, 2017
Actual Study Completion Date : April 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Saturn nasal mask
Participants to use nasal mask in-home for 7 ± 3 days
Device: Saturn nasal mask
Nasal mask for the treatment of obstructive sleep apnea (OSA)




Primary Outcome Measures :
  1. Comfort [ Time Frame: Up to 7 ± 3 days in-home ]
    Subjective questionnaire

  2. Stability [ Time Frame: Up to 7 ± 3 days in-home ]
    Subjective questionnaire

  3. Objective leak data [ Time Frame: Up to 7 ± 3 days in-home ]
    Obtained from participant's CPAP device

  4. Subjective measurement of leak [ Time Frame: Up to 7 ± 3 days in-home ]
    Subjective questionnaire

  5. Draft [ Time Frame: Up to 7 ± 3 days in-home ]
    Subjective questionnaire

  6. Treatment efficacy [ Time Frame: Up to 7 ± 3 days in-home ]
    Obtained from participant's CPAP device

  7. Noise [ Time Frame: Up to 7 ± 3 days in-home ]
    Subjective questionnaire


Secondary Outcome Measures :
  1. Preference of mask [ Time Frame: Up to 7 ± 3 days in-home ]
    Subjective questionnaire

  2. Usability [ Time Frame: Up to 7 ± 3 days in-home ]
    Subjective questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult (18+ years of age)
  • Able to give consent
  • AHI ≥ 5 on diagnostic night
  • Prescribed a CPAP device after successful OSA diagnosis
  • Existing nasal or nasal pillow mask user

Exclusion Criteria:

  • Inability to give consent
  • Participants 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03075722


Locations
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New Zealand
Bowen Hospital
Wellington, New Zealand, 6035
Sponsors and Collaborators
Fisher and Paykel Healthcare

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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT03075722     History of Changes
Other Study ID Numbers: CIA-205
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: April 20, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with anyone

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases