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

NCT ID: NCT05818540

Last Updated: 2025-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-17

Study Completion Date

2023-12-29

Brief Summary

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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

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Data collected will be deidentified upon collection - surveys and assessment forms will be labelled with a numerical identifier.

Study Groups

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Eclipse novel mask

Human subjects will use the Eclipse CPAP interface for 60 days for a total of 6 hours per night.

Group Type EXPERIMENTAL

Eclipse novel CPAP mask

Intervention Type DEVICE

Participants will wear the mask for 6 hours a night for 60 days.

Traditional CPAP mask

Human subjects will use the ResMed P-10 CPAP interface for 60 days for a total of 6 hours per night.

Group Type ACTIVE_COMPARATOR

ResMed P-10 mask

Intervention Type DEVICE

Participants will wear the mask for 6 hours a night for 60 days.

Interventions

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Eclipse novel CPAP mask

Participants will wear the mask for 6 hours a night for 60 days.

Intervention Type DEVICE

ResMed P-10 mask

Participants will wear the mask for 6 hours a night for 60 days.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Bleep, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stuart Heatherington

Role: PRINCIPAL_INVESTIGATOR

Bleep, LLC

Locations

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Sleep Centers of Middle Tennessee

Murfreesboro, Tennessee, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R44HL158286-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

BSL-SNAP-003

Identifier Type: -

Identifier Source: org_study_id