Sleep ApneaPhase 3NCT01286636
Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
A Phase 3 study testing computer model and Polysomnogram in people with Sleep Apnea, run by State University of New York at Buffalo at 1 site in United States.
Trial summary
The investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (CDSS) not only to detect the presence of sleep apnea but also to predict its severity. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- computer model and Polysomnogram
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jun 2015
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be an adult (≥18 years old)
- Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider.
Who cannot join
- Pregnancy or breast feeding
- Patients with severe congestive heart failure (eg, NYHA Class IV, ejection fraction < 35%).
- Patients with end-stage renal disease on hemodialysis
- Patients with CVA, Parkinson, neuromuscular degenerative disease.
- Patient on narcotics.
- Patients with severe lung disease requiring oxygen at night and/or during the day.
- Patient with predominant insomnia or sleep hygiene problems, and who are not considered for PSG by the sleep specialist.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veterans Affairs Medical Center in Buffalo
Buffalo, New York, 14215
About this study
The investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (CDSS) not only to detect the presence of sleep apnea but also to predict its severity. The CDSS is based on deploying an artificial neural network (ANN) derived from anthropomorphic and clinical characteristics.
The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be diagnosed with the use of ANN without undergoing a sleep study, and that empiric management with auto-CPAP has similar outcomes to those who undergo a formal sleep study.
- Conditions
- Sleep Apnea
- Being tested
- computer model, Polysomnogram
- Keywords
- artificial neural network
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer modelOther
Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.
PolysomnogramOther
Diagnosis of sleep apnea will rely on polysomnogram
| Study group | Role | What they receive |
|---|---|---|
| artificial neural network | Experimental | Not described Receives: Other: computer model |
| Polysomnogram | Active comparator | Not described Receives: Other: Polysomnogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate that using an ANN directed management of OSA is not inferior to PSG directed management of OSA in terms of sleepiness related functional outcome
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionMar 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe 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 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Principal investigator, Ali El Solh, State University of New York at Buffalo
- Investigators
- Ali El-Solh, MD, MPH, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286636
- Sponsor's protocol ID
- ANN02
- Status last verified
- Jan 2016
- First submitted
- 27 Jan 2011
- Last updated
- 13 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Neural Network Directed Therapy of Severe Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT01286636
- Acronym / sponsor ID
- ANN02
- Conditions
- Sleep Apnea
- Keywords
- artificial neural network
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- Jan 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Jan 2011 (estimated)
- 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 investigators have developed a simple, accurate, and a point-of-care, computer-based clinical decision support system (CDSS) not only to detect the presence of sleep apnea but also to predict its severity. The CDSS is based on deploying an artificial neural network (ANN) derived from anthropomorphic and clinical characteristics.
The investigators hypothesize that patients with severe OSA defined as AHI≥30 can be diagnosed with the use of ANN without undergoing a sleep study, and that empiric management with auto-CPAP has similar outcomes to those who undergo a formal sleep study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artificial neural network | Experimental | Other: computer model |
| Polysomnogram | Active comparator | Other: Polysomnogram |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be an adult (≥18 years old)
- Must have symptoms suggestive of OSA, and be considered for sleep study by the sleep specialist provider.
Key exclusion criteria (7 listed)
- Pregnancy or breast feeding
- Patients with severe congestive heart failure (eg, NYHA Class IV, ejection fraction < 35%).
- Patients with end-stage renal disease on hemodialysis
- Patients with CVA, Parkinson, neuromuscular degenerative disease.
- Patient on narcotics.
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 |
|---|---|---|
| computer modelDiagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction. | Other | artificial neural network |
| PolysomnogramDiagnosis of sleep apnea will rely on polysomnogram | Other | Polysomnogram |
Primary outcome
To demonstrate that using an ANN directed management of OSA is not inferior to PSG directed management of OSA in terms of sleepiness related functional outcome
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2016.
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
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.
Ali El-Solh, MD, MPH principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing computer model and Polysomnogram in people with Sleep Apnea, run by State University of New York at Buffalo at 1 site 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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
To demonstrate that using an ANN directed management of OSA is not inferior to PSG directed management of OSA in terms of sleepiness related functional outcome (time frame: 6 weeks). 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 13 Jan 2016.