Obstructive Sleep Apnea of AdultNCT04643782
Comparative Study of the ANNE™ One System to Diagnose Obstructive Sleep Apnea
A study testing ANNE Sleep in people with Obstructive Sleep Apnea of Adult, run by Northwestern University at 4 sites in United States.
Trial summary
The main objective of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea of Adult
- What is being tested?
- ANNE Sleep
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 4 sitesUnited States
- Study dates
- 11 May 2021to 27 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥22 years old.
- Subjects with suspected OSA based on history and physical who qualify for, and have either a PSG or HSAT ordered, as determined by their regular provider. Subjects with self-reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. Persons with a previous diagnosis of OSA are also eligible.
- Willingness to give written consent and comply with study procedures
Who cannot join
- An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection
- Inability to understand instructions
- Has a skin abnormality that precludes assessment
- Has a history of dementia
- Patients with implanted pacemakers or defibrillators
- Subject is pregnant, nursing or planning a pregnancy over the expected course of the study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Northwestern Lake Forest Hospital
Lake Forest, Illinois, 60045
Carle Foundation Hosipital
Urbana, Illinois, 61801
Central Dupage Hospital (CDH)
Winfield, Illinois, 60190
About this study
Official title: A Single Arm, Open-Label, Multi-Center, and Comparative Study of the Anne Sleep System Versus Polysomnography to Diagnose Obstructive Sleep Apnea: ANNE Program for the Non-Invasive Evaluation of Apnea in Sleep (APNEAs)
The main objective of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults
Read the detailed description
The main object of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNE Sleep system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea
- Conditions
- Obstructive Sleep Apnea of Adult
- Being tested
- ANNE Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANNE SleepDevice
ANNE sleep system
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Other | After consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night. Receives: Device: ANNE Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography
The diagnosis of moderate to severe OSA by determining a patient's Apnea-Hypopnea Index (AHI) using the ANNE Sleep system compared to Polysomnography (PSG) over one (1) night worn concurrently.
Sensitivity is the number of true positives divided by the sum of the number of true positives and false negatives. Specificity is the number of true negatives divided by the sum of the number of true negatives and false positives.
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start11 May 2021
- Primary completion17 Nov 2021
- Study completion27 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will use ANNE Sleep system during one night of polysomnography recording in sleep lab.
- Masking
- None (open label)
- Enrolment
- 287 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Sibel Health Inc.
- Responsible party
- Principal investigator, Phyllis Zee, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643782
- Sponsor's protocol ID
- STU0021444
- Status last verified
- Jan 2023
- First submitted
- 16 Nov 2020
- Last updated
- 14 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data stored and used for future research will be de-identified. Data will not be used for future research outside of the scope of this study.
Publications
Davies C, Lee JY, Walter J, Kim D, Yu L, Park J, Blake S, Kalluri L, Cziraky M, Stanek E, Miller J, Harty BJ, Schauer J, Rangel SM, Serao A, Edel C, Ran DS, Olagbenro MO, Lim A, Gill K, Cooksey J, Toloui O, Power T, Xu S, Zee P. A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea. J Clin Sleep Med. 2022 Dec 1;18(12):2703-2712. doi: 10.5664/jcsm.10194.
PubMed 35934926
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open-Label, Multi-Center, and Comparative Study of the Anne Sleep System Versus Polysomnography to Diagnose Obstructive Sleep Apnea: ANNE Program for the Non-Invasive Evaluation of Apnea in Sleep (APNEAs)
- ClinicalTrials.gov ID
- NCT04643782
- Acronym / sponsor ID
- STU0021444
- Conditions
- Obstructive Sleep Apnea of Adult
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Sibel Health Inc.
- Study start
- 11 May 2021 (actual)
- Primary completion
- 17 Nov 2021 (actual)
- Study completion
- 27 Dec 2021 (actual)
- First posted
- 25 Nov 2020 (actual)
- Results
- Posted 14 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults
Detailed description
The main object of this study is to evaluate the accuracy of the ANNE Sleep system for the diagnosis of obstructive sleep apnea (OSA) in adults. Our primary hypothesis is that the ANNE Sleep system is non-inferior compared to polysomnography (PSG) for the diagnosis of obstructive sleep apnea
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will use ANNE Sleep system during one night of polysomnography recording in sleep lab.
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Other | Device: ANNE SleepAfter consent, subjects will wear the ANNE sleep system during an attended PSG study for 1 night. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥22 years old.
- Subjects with suspected OSA based on history and physical who qualify for, and have either a PSG or HSAT ordered, as determined by their regular provider. Subjects with self-reported symptoms of OSA based on the STOP-Bang questionnaire indicating affirmative answers to any of the following: snoring, daytime fatigue/sleepiness/tiredness, partners who have observed the subject stopping breathing or choking/gasping during sleep. Persons with a previous diagnosis of OSA are also eligible.
- Willingness to give written consent and comply with study procedures
Key exclusion criteria (6 listed)
- An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related to this trial or interferes with the clinical trial and data collection
- Inability to understand instructions
- Has a skin abnormality that precludes assessment
- Has a history of dementia
- Patients with implanted pacemakers or defibrillators
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 |
|---|---|---|
| ANNE SleepANNE sleep system | Device | Single Arm Study |
Primary outcome
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography
Time frame: 1 night
The diagnosis of moderate to severe OSA by determining a patient's Apnea-Hypopnea Index (AHI) using the ANNE Sleep system compared to Polysomnography (PSG) over one (1) night worn concurrently. Sensitivity is the number of true positives divided by the sum of the number of true positives and false negatives. Specificity is the number of true negatives divided by the sum of the number of true negatives and false positives.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35934926Davies C, Lee JY, Walter J, Kim D, Yu L, Park J, Blake S, Kalluri L, Cziraky M, Stanek E, Miller J, Harty BJ, Schauer J, Rangel SM, Serao A, Edel C, Ran DS, Olagbenro MO, Lim A, Gill K, Cooksey J, Toloui O, Power T, Xu S, Zee P. A single-arm, open-label, multicenter, and comparative study of the ANNE sleep system vs polysomnography to diagnose obstructive sleep apnea. J Clin Sleep Med. 2022 Dec 1;18(12):2703-2712. doi: 10.5664/jcsm.10194.
- Individual participant dataSharing planned: No. Data stored and used for future research will be de-identified. Data will not be used for future research outside of the scope of this study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ANNE Sleep in people with Obstructive Sleep Apnea of Adult, run by Northwestern University at 4 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 3 inclusion and 6 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
Yes. Results are posted in the registry (first posted 14 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity and Specificity of Obstructive Sleep Apnea (OSA) Diagnosis Using ANNE Sleep System Compared to Polysomnography (time frame: 1 night). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04643782, which also lists 1 linked publication.
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 14 Feb 2023.