Sleepnet Elara APAP Device for Sleep Apnea

AB
Overseen ByAndrea Brown, M.S.
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Sleepnet Corporation
Must be taking: APAP device
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the Sleepnet Elara APAP device aids individuals with obstructive sleep apnea (OSA) in breathing more easily during sleep. The focus is on determining whether this device can enhance sleep quality for those already using a similar device for their OSA. Participants diagnosed with OSA by a doctor in the last six months and experiencing frequent nighttime breathing interruptions may be suitable candidates. As an unphased trial, this study provides participants the chance to contribute to valuable research that could improve sleep apnea treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study focuses on sleep apnea treatment, it's best to discuss your medications with the study team to ensure they won't interfere with the trial.

What prior data suggests that the Sleepnet Elara APAP device is safe for sleep apnea?

In a previous study, researchers tested the Sleepnet Elara APAP device for safety in treating sleep apnea. Research has shown that most patients handle this device well, with no major reports of problems directly caused by the device itself. However, Sleepnet recalled some masks with magnets due to potential interference with other medical devices. This issue involved the masks, not the APAP device under study. Overall, past research has demonstrated a promising safety record for the Elara APAP device.12345

Why are researchers excited about this trial?

The Sleepnet Elara APAP Device is unique because it offers an advanced, adaptable approach to treating sleep apnea. Unlike traditional CPAP machines that deliver a constant pressure, the Elara APAP adapts the pressure automatically based on the user's needs throughout the night. This tailored pressure adjustment can lead to more comfort and potentially better adherence to therapy. Researchers are excited about this device as it aims to improve user experience and effectiveness over conventional options, which could lead to better overall management of sleep apnea.

What evidence suggests that the Sleepnet Elara APAP device is effective for sleep apnea?

Studies have shown that the Sleepnet Elara APAP device effectively treats obstructive sleep apnea. Research indicates that this device improves sleep quality by automatically adjusting air pressure to keep airways open. In previous studies, patients using the Elara APAP device experienced better sleep and fewer sleep apnea symptoms. Additionally, patients find the device easy to use and well-liked. Overall, the Sleepnet Elara APAP device effectively manages sleep apnea.12678

Who Is on the Research Team?

AM

Anthony McLeod, MD

Principal Investigator

University Sleep Disorders Center

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) who weigh at least 30 kg, have been diagnosed with obstructive sleep apnea in the past 6 months (with moderate to severe symptoms), and are already using an APAP device for treatment. Participants must be able to consent and follow study instructions.

Inclusion Criteria

2. Willing and able to consent, adhere to study requirements and receive mask treatment
I am 18 years old or older.
My body weight is at least 30 kilograms.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 night
1 visit (in-person)

Treatment

Participants use the Elara APAP device during a 1-night in-lab PSG to assess efficacy

1 night
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Sleepnet Elara APAP Device

Trial Overview

The study is testing the effectiveness of the Sleepnet Elara APAP device, a machine that automatically adjusts air pressure during sleep to treat obstructive sleep apnea.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sleepnet Corporation

Lead Sponsor

Citations

A Study of the Sleepnet Elara APAP Device

A prospective open label study to assess the efficacy of the Elara APAP device when used in patients with obstructive sleep apnea.

Sleepnet Elara APAP Device for Sleep Apnea

The goal of this study is to evaluate the effectiveness of the Elara APAP device. Who Is on the Research Team? AM. Anthony McLeod, MD.

Clinical Evidence in the Treatment of Obstructive Sleep ... - PMC

A common finding was the positive responsiveness of oral appliance treatment in subjects affected by mild-to-moderate OSA with some evidence for cases of ...

Obstructive Sleep Apnea: CPAP and AHI vs. outcomes

Cardiovascular mortality in obstructive sleep apnoea treated with continuous positive airway pressure or oral appliance: an observational study.

Different Oral Appliance Designs Demonstrate ...

Oral Appliance Therapy has emerged as a leading non-CPAP treatment for patients with Obstructive Sleep Apnea. Historically, healthcare providers have questioned ...

Sleep Apnea Masks Recalled by Sleepnet

Sleepnet Corporation recalled all its CPAP and BIPAP sleep apnea masks that have magnets because they may interfere with certain medical devices.

Legal Information - Sleepnet Corporation Respiratory Masks

CPAP, NIV, Pediatric Masks. Sleep apnea, Homecare, Hospital, Full-face, nasal masks. Quality respiratory masks made in the United States. Best CPAP masks.

SleepNet Corporation Recalls Continuous Positive Airway ...

On March 1, 2024 Sleepnet Corporation issued a voluntarily recall on masks with magnets which are intended to be used with positive airway ...