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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02541214
• Other study ID #: CIA-171
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: November 2015

Study information

• Verified date: July 2019
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Trial Nasal Mask

Locations

Country	Name	City	State
New Zealand	Waikato District Health Board	Hamilton
New Zealand	Hawke's Bay District Health Board	Hastings

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire		2 weeks in home
Secondary	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.	the participant would choose from a 5 point likert scale on a questionnaire. The scale range from "very good" to "very poor"	2 weeks in home
Secondary	Objective leak data through the Positive Airway Pressure therapy device	Evaluating the leak of the trial Nasal mask	2 weeks in home
Secondary	Treatment efficacy through the Positive Airway Pressure therapy device	Evaluating the number of apnea/hypopnea per hour	2 weeks in home
Secondary	Preference of the Trial Nasal mask compared to the participant's usual mask through a custom questionnaire.	the participant would either choose the trial Nasal mask or their usual mask as their primary mask	2 weeks in home