Field Usability Study of Eclipse Mask

Obstructive Sleep Apnea Clinical Trial

Official title:

Field Usability Study of Eclipse CPAP Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05559047
• Other study ID #: BSL-SNAP-002
• Secondary ID: 1R44HL158286-01A
• Status: Completed
• Phase: N/A
• Start date: November 10, 2022
• Est. completion date: January 25, 2023

Study information

• Verified date: January 2023
• Source: Bleep, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is designed to assess the usability of a novel CPAP human interface compared to a traditional nasal mask. Human subjects will interact with two different CPAP interfaces including a traditional CPAP mask and the 2nd generation DreamPort-Eclipse. Subjects will be requested to put on each of the different CPAP interface options a total of three times for a total of 6 trials. The order of device will be randomized.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 25, 2023
• Est. primary completion date: January 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

•Male or female =18 years old who are impacted by obstructive sleep apnea and currently are familiar with a CPAP device.

Exclusion Criteria:

• Diagnosis of any medical or behavioral conditions that would compromise subject safety.

• Under the age of 18: target for this current version of the platform is the adult population.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Device:
• Eclipse novel CPAP mask
Participants will follow instructions to set up and put on the Eclipse nasal mask. The Eclipse removes the headgear associated with traditional CPAP masks, offering a small compact design weighing less than an ounce. The Eclipse uses small and lightweight adhesive seals around the nostrils to create an ergonomic design which accommodates the shape of each individual user. It completes a perfect circuit for CPAP therapy to deliver pressure to the airway and stabilize the user's disordered breathing during sleep (apnea and snoring). Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.
• Phillips Respironics Nuance
Participants will follow instructions to set up and put on the Respironics Nuance, traditional nasal mask. Participants will follow instructions to set up and put on the mask. They will fill out a survey about the ease and comfort of putting on and wearing the mask, briefly.

Locations

Country	Name	City	State
United States	AeroFlow Sleep	Asheville	North Carolina
United States	Advanced Respiratory and Sleep Medicine	Huntersville	North Carolina
United States	Sleep Centers of Middle Tennessee	Murfreesboro	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Bleep, LLC	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete each setup	We will record the time it takes the participant to set up and try on each device.	1 day
Primary	Number of technical issues	We will record the number of observed technical issues that occurred when the participant attempts to set up and try on the device.	1 day
Primary	Number of times participant needs assistance	We will record the number of times each participant requires assistance or additional instructions setting up and trying on each device.	1 day