A Study of the Sleepnet Elara APAP Device
ConditionSleep Apnea - Obstructive
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSleepnet Corporation
About this trial
The goal of this study is to evaluate the effectiveness of the Elara APAP device.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Sleepnet Elara Treatment
DeviceSubject to have a 1 night in-lab PSG
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
AHI 4%
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.
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: