Sleep Apnea - ObstructiveNCT07559708
A Study of the Sleepnet Elara APAP Device
A study testing Sleepnet Elara Treatment in people with Sleep Apnea - Obstructive, run by Sleepnet Corporation at 2 sites in United States.
Trial summary
The goal of this study is to evaluate the effectiveness of the Elara APAP device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea - Obstructive
- What is being tested?
- Sleepnet Elara Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 2 sitesUnited States
- Study dates
- 21 Apr 2026to 20 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
- Severe nasal congestion from various causes
- Lung bullae
- Central sleep apnea index >5 events/hr
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
University Sleep Disorders Center
Auburn, Alabama, 36832
Clayton Sleep Institute
St Louis, Missouri, 63123
About this study
Official title: A Prospective, Open-label Study to Assess the Efficacy of the Elara APAP Device When Used in Patients With Obstructive Sleep Apnea
The goal of this study is to evaluate the effectiveness of the Elara APAP device.
Read the 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.
- Conditions
- Sleep Apnea - Obstructive
- Being tested
- Sleepnet Elara Treatment
- Keywords
- OSA, Sleep Apnea, APAP, Polysomnography, Obstructive Sleep Apnea, Sleep Study
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleepnet Elara TreatmentDevice
Subject to have a 1 night in-lab PSG
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Sleepnet Elara Treatment Receives: Device: Sleepnet Elara Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start21 Apr 2026
- Primary completion20 Oct 2026
- Study completion20 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea - ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sleepnet Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony McLeod, MD, Principal investigator, University Sleep Disorders Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559708
- Sponsor's protocol ID
- SN-APAP-001
- Status last verified
- Oct 2026
- First submitted
- 19 Apr 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Not required.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label Study to Assess the Efficacy of the Elara APAP Device When Used in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT07559708
- Acronym / sponsor ID
- SN-APAP-001
- Conditions
- Sleep Apnea - Obstructive
- Keywords
- OSA, Sleep Apnea, APAP, Polysomnography, Obstructive Sleep Apnea, Sleep Study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Sleepnet CorporationIndustry (pharma, biotech, devices)
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 20 Oct 2026 (actual)
- Study completion
- 20 Oct 2026 (actual)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Sleepnet Elara TreatmentSleepnet Elara Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleepnet Elara TreatmentSubject to have a 1 night in-lab PSG | Device | Treatment |
Primary outcome
AHI 4%
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. Not required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony McLeod, MD principal investigator
University Sleep Disorders Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleepnet Elara Treatment in people with Sleep Apnea - Obstructive, run by Sleepnet Corporation at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AHI 4% (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.