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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04063436
• Other study ID #: CIA-264
• Status: Withdrawn
• Phase: N/A
• Start date: September 23, 2019
• Est. completion date: October 11, 2019

Study information

• Verified date: March 2020
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Are =22 years of age

• Weigh =66 lbs

• Have been formally diagnosed with OSA by a physician

• Have an AHI =5 on a diagnostic night

• Have been prescribed PAP therapy to treat OSA by a physician

• Are an existing nasal pillows mask user

• Have been using a nasal pillows mask for =3 months prior to enrolment into the study

• Are compliant with PAP therapy for =4 hours per night for 70% of nights

• Are fluent in spoken and written English

• Possess the capacity to provide informed consent

Exclusion Criteria:

• Are intolerant to PAP therapy

• Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate

• Are currently diagnosed with respiratory disease or CO2 retention

• Are pregnant or think they may be pregnant

• Have an IPAP pressure of >25 cmH2O

• Persons who use a PAP therapy machine for the delivery of medicines, except O2

• Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI

Related Conditions & MeSH terms

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

Intervention

Device:
• New nasal pillows mask with PAP therapy
Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.

Locations

Country	Name	City	State
United States	Ohio Sleep Medicine Institute	Dublin	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance of new nasal pillows mask	The new nasal pillows mask provides adequate PAP therapy for OSA when used in a home environment. This is an objective measure and is determined by the Apnea-Hypopnea Index recorded on PAP therapy machines.	14±5 days
Secondary	Comfort of new nasal pillows mask	The new nasal pillows mask is comfortable during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.	14±5 days
Secondary	Usability of new nasal pillows mask	The new nasal pillows mask is user-friendly during PAP therapy for OSA when used in a home environment. This is a subjective measure and is determined by a five-point Likert-type scale as recorded on a questionnaire.	14±5 days