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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: ResMed P-10 mask; Device: Eclipse novel CPAP mask

• Registration Number: NCT05818540
• Lead Sponsor: Bleep, LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study Start: 2023-04-17
• Study First Submitted QC: 2023-04-17
• Study First Posted: 2023-04-19
• Primary Completion: 2023-12-29
• Study Completion: 2023-12-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional CPAP mask	ResMed P-10 mask	Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.
Eclipse novel mask	Eclipse novel CPAP mask	Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index (AHI)	60 days	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.
Leak	60 days	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.
CPAP Device Pressure	60 days	CPAP device pressure is expected to decrease with decrease leak with the novel mask.

Secondary Outcome Measures

Name	Time	Method
Participant satisfaction with the mask choice:	60 days	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.
Mask Acceptance	60 days	Mask acceptance will be defined by continued use versus discontinued use

Trial Locations

Locations (1)

Sleep Centers of Middle Tennessee; 🇺🇸 Murfreesboro, Tennessee, United States