NCT07559708Not yet recruitingNot Applicable
A Prospective, Open-label Study to Assess the Efficacy of the Elara APAP Device When Used in Patients With Obstructive Sleep Apnea
Sleepnet Corporation1 site in 1 country55 target enrollmentStarted: April 27, 2026Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 55
- Locations
- 1
- Primary Endpoint
- AHI 4%
Study Overview
Brief Summary
The goal of this study is to evaluate the effectiveness of the Elara APAP device.
Detailed Description
A prospective open label study to assess the efficacy of the Elara APAP device when used in patients with obstructive sleep apnea. Subjects will sign Informed Consent and undergo screening/baseline and a 1 night in-lab PSG.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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).
Arms & Interventions
Treatment
Experimental
Sleepnet Elara Treatment
Intervention: Sleepnet Elara Treatment (Device)
Outcomes
Primary Outcomes
AHI 4%
Time Frame: Day 1
The primary endpoint of this study is treatment night AHI 4%. A subject is considered a success if the Apnea Hypopnea Index calculated by using hypopneas that cause a 4% or greater drop in blood oxygen levels per hour of sleep (AHI4) measured during the 1-night treatment study (PSG) is less than 10 events/hour or less than 10% of the baseline AHI4 value determined at previous diagnosis, whichever is greater.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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