Sleep Apnea - Obstructive
Conditions
Keywords
OSA, Sleep Apnea, APAP, Polysomnography, Obstructive Sleep Apnea, Sleep Study
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.
Interventions
DEVICESleepnet Elara Treatment
Subject to have a 1 night in-lab PSG
Sponsors
Sleepnet Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Body weight ≥ 30kg 2. Willing and able to consent, adhere to study requirements and receive mask treatment 3. ≥ 18 years of age 4. 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) 5. Currently utilizing an APAP Device for ongoing treatment of OSA
Exclusion criteria
1. Body weight \< 30kg 2. Female currently bearing a child or intending to become pregnant prior to the sleep study. 3. Have implanted pacemaker, ICD or any other medical device that would interfere with the PSG results or safety of the subject undergoing the study 4. Has pneumothorax, pneumomediastinum 5. Has history of Cerebrospinal fluid leakage, craniocerebral trauma, intracranial trauma or pneumocephalus 6. Ongoing shock from various causes untreated 7. Current epistaxis 8. Non-compliant with APAP usage (\< 4 hours per night on 70% of nights) 9. Upper gastrointestinal bleeding that has not been effectively controlled 10. Has obstructive vocal cord polyps 11. Severe coronary heart disease with left heart failure 12. Acute otitis media inflammation (must be resolved prior to sleep study) 13. Excessive respiratory secretions and cough weakness 14. Weak spontaneous breathing 15. Tracheal intubation (nasal or oral) and tracheotomy 16. Severe nasal congestion from various causes 17. Lung bullae 18. Central sleep apnea index \>5 events/hr 19. 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AHI 4% | 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. |
Countries
United States
Contacts
CONTACTAndrea Brown, M.S.
PRINCIPAL_INVESTIGATORAnthony McLeod, MD
University Sleep Disorders Center
Outcome results
None listed