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

• Sponsor: Fisher and Paykel Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02541214
• Collaborator: (none)
• Enrollment: 39
• Locations: 2
• Arm: 1
• Duration (Months): 2
• Patients Per Site: 19.5
• Patients Per Site Per Month: 9.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Device: Trial Nasal Mask	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Oct 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Trial Nasal Mask The participant will use the Saturn nasal mask for 2 weeks in home	Device: Trial Nasal Mask

Outcome Measures

Primary Outcome Measures

1. Subjective measurements of comfort on the trial Nasal Mask gathered through a custom questionnaire [2 weeks in home]

Secondary Outcome Measures

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. [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 [2 weeks in home]

   Evaluating the leak of the trial Nasal mask

3. Treatment efficacy through the Positive Airway Pressure therapy device [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. [2 weeks in home]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Waikato District Health Board	Hamilton		New Zealand	3240
2	Hawke's Bay District Health Board	Hastings		New Zealand	9014

Sponsors and Collaborators

• Fisher and Paykel Healthcare

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fisher and Paykel Healthcare
• ClinicalTrials.gov Identifier: NCT02541214
• Other Study ID Numbers: CIA-171
• First Posted: Sep 4, 2015
• Last Update Posted: Aug 2, 2019
• Last Verified: Jul 1, 2019

• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Aug 2, 2019