Recruiting

Elara APAP

Sponsor:

Sleepnet Corporation

Code:

NCT07559708

Conditions

Sleep Apnea - Obstructive

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sleepnet Elara Treatment

Study Details

Brief summary:

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

Conditions

Sleep Apnea - Obstructive

Study ID

NCT07559708

Start date

Apr 21, 2026

Status verified date

Oct, 2026

Completion date

Oct 30, 2026

Anticipated

Primary completion date

Oct 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

Sleepnet Elara Treatment

Interventions

Sleepnet Elara Treatment

Subject to have a 1 night in-lab PSG

Primary outcome measure

  • AHI 4% [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Locations

University Sleep Disorders Center

Recruiting

Auburn, Alabama, United States, 36832

Contacts

Principal Investigator:

Anthony McLeod, MD

Clayton Sleep Institute

Recruiting

St Louis, Missouri, United States, 63123

Contacts

Matthew Uhles, MS, RPSGT, RST

314-645-5855uhlesm@claytonsleep.com

Principal Investigator:

Matthew Uhles, MS, RPSGT, RST

More Information

Sponsor

Sleepnet Corporation

Last update posted

Oct 27, 2026

Last verified

Oct, 2026

Keywords

  • OSA
  • Sleep Apnea
  • APAP
  • Polysomnography
  • Obstructive Sleep Apnea
  • Sleep Study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-28. This information was provided to ClinicalTrials.gov by Sleepnet Corporation on 2026-10-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.