A Study of the Sleepnet Elara APAP Device

Sleepnet Corporation

Status: Not yet enrolling

Conditions: Sleep Apnea - Obstructive

Treatments: Device: Sleepnet Elara Treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT07559708

SN-APAP-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Treatment

Experimental group

Description:

Sleepnet Elara Treatment

Treatment:

Device: Sleepnet Elara Treatment