Sleep Apnea Study in Adults Using DreamPort-Eclipse and a Traditional Nasal Mask

Obstructive Sleep Apnea Clinical Trial

Official title:

Randomized Controlled Trial to Compare Effectiveness of DreamPort-Eclipse to a Traditional Nasal Mask

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05818540
• Other study ID #: BSL-SNAP-003
• Secondary ID: 1R44HL158286-01A
• Status: Completed
• Phase: N/A
• Start date: April 17, 2023
• Est. completion date: December 29, 2023

Study information

• Verified date: February 2024
• Source: Bleep, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Randomized Controlled Trial of Bleep DreamPort-Eclipse Study is a two-arm, randomized, prospective, non-blinded study to assess the effectiveness of the novel CPAP human interface design to improve leak, AHI, and pressure compared to a traditional nasal mask.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 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:

• Any medical or behavioral conditions that would compromise subject safety
• Under the age of 18 years old

Related Conditions & MeSH terms

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

Intervention

Device:
• Eclipse novel CPAP mask
Participants will wear the mask for 6 hours a night for 60 days.
• ResMed P-10 mask
Participants will wear the mask for 6 hours a night for 60 days.

Locations

Country	Name	City	State
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	Apnea-Hypopnea Index (AHI)	The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The apneas (pauses in breathing) must last for at least 10 seconds and be associated with a decrease in blood oxygenation. For OSA treatment, we are looking to see AHI decrease to <5.	60 days
Primary	Leak	Leak can be caused by several issues- having the wrong mask size or type, the mask not being assembled or fitted correctly, or parts being worn out and needing replacement. The acceptable leak rate is up to 24 litres per minute. Anything below this means the patient is still getting the full benefits of therapy.	60 days
Primary	CPAP Device Pressure	CPAP device pressure is expected to decrease with decrease leak with the novel mask.	60 days
Secondary	Participant satisfaction with the mask choice:	Survey title: Bleep Sleep (BSL)-SNAP-003 Participant Survey; Satisfaction will be based on a participant questionnaire in which they indicate their overall satisfaction with the mask they are assigned.Lower score indicates higher patient satisfaction. Scale is as follows: Strongly disagree, Disagree, Neither agree or disagree, Agree, Strongly Agree.	60 days
Secondary	Mask Acceptance	Mask acceptance will be defined by continued use versus discontinued use	60 days