A Study of the Sleepnet Elara APAP Device

NCT07559708 | Not Yet Recruiting FDA Device

• 1 other identifier: SN-APAP-001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Apnea - Obstructive

Keywords

OSA; Sleep Apnea; APAP; Polysomnography; Obstructive Sleep Apnea; Sleep Study

Outcome Measures

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.

  Day 1

Study Arms (1)

Treatment

EXPERIMENTAL

Sleepnet Elara Treatment

Device: Sleepnet Elara Treatment

Interventions

Sleepnet Elara Treatment DEVICE

Subject to have a 1 night in-lab PSG

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sleepnet Corporation: lead

Study Sites (1)

University Sleep Disorders Center

Auburn, Alabama, 36832, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Anthony McLeod, MD

  University Sleep Disorders Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Brown, M.S.

CONTACT

408-881-2611; abrown@abioclinical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 30, 2026
• Study Start: April 27, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)