A Study of the Sleepnet Elara APAP Device

Starting soon · Not applicable

Conditions studied: Sleep Apnea - Obstructive

In brief

The goal of this study is to evaluate the effectiveness of the Elara APAP device.

Key facts

Study ID

NCT07559708

Run by

Sleepnet Corporation

People needed

55

Starts

2026-04-27

Expected to finish

2026-06-30

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Body weight ≥ 30kg
• Willing and able to consent, adhere to study requirements and receive mask treatment
• ≥ 18 years of age
• Diagnosed with OSA (Total AHI >15 events/hr) by a practicing physician within the last 6 months. A re-diagnosis may be necessary to establish current baseline AHI in case there has been significant weight change or other co-morbidities since the previous diagnosis (per PI discretion)
• Currently utilizing an APAP Device for ongoing treatment of OSA

You may not qualify if…

• Body weight < 30kg
• Female currently bearing a child or intending to become pregnant prior to the sleep study.
• Have implanted pacemaker, ICD or any other medical device that would interfere with the PSG results or safety of the subject undergoing the study
• Has pneumothorax, pneumomediastinum
• Has history of Cerebrospinal fluid leakage, craniocerebral trauma, intracranial trauma or pneumocephalus
• Ongoing shock from various causes untreated
• Current epistaxis
• Non-compliant with APAP usage (< 4 hours per night on 70% of nights)
• Upper gastrointestinal bleeding that has not been effectively controlled
• Has obstructive vocal cord polyps
• Severe coronary heart disease with left heart failure
• Acute otitis media inflammation (must be resolved prior to sleep study)
• Excessive respiratory secretions and cough weakness
• Weak spontaneous breathing
• Tracheal intubation (nasal or oral) and tracheotomy
• Severe nasal congestion from various causes
• Lung bullae
• Central sleep apnea index >5 events/hr
• Have another significant sleep disorder(s) that in the opinion of the investigator would confound the results of the study (e.g. periodic leg movements >15/hr or insomnia that would interfere with completing the sleep study).

Where it is running

• University Sleep Disorders Center — Auburn, Alabama, United States

Full record on ClinicalTrials.gov

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