Obstructive Sleep ApneaNCT07826143
Automated vs Manual Polysomnography Scoring in Adults With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Ain Shams University at 1 site in Egypt.
Trial summary
This prospective study aims to compare automated polysomnographic scoring with manual scoring in adult patients with Obstructive Sleep Apnea (OSA). The main objective is to evaluate the accuracy, reliability, and time efficiency of automated scoring algorithms compared to standard manual scoring performed by expert… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Polysomnographic Scoring (Automated vs. Manual)
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2027to Feb 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Patients referred to the sleep unit with suspected OSA who are scheduled for an overnight diagnostic PSG.
Who may be able to join
- Age > 18 years.
- Clinical suspicion of OSA based on history, physical examination, and a positive screening questionnaire (e.g., STOP-BANG ≥ 3).
- Ability to provide written informed consent.
Who cannot join
- Age ≤ 18 years.
- Inability to give informed consent (e.g., severe cognitive impairment, language barrier).
- Contraindications to PSG (e.g., severe skin conditions preventing electrode placement).
- Current use of therapies that could alter sleep architecture (e.g., highdose benzodiazepines, opioids) unless a wash-out period is observed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ain shams university hospitals
Cairo, Cairo Governorate
Amira Elghonemy, MD candidate, +201032438035, amiraelghonemy07@gmail.com
Amira Elghonemy, MD candidate
About this study
Official title: Automated Versus Manual Polysomnographic Scoring in Adult Patients With Obstructive Sleep Apnea: A Prospective Comparative Study
This prospective study aims to compare automated polysomnographic scoring with manual scoring in adult patients with Obstructive Sleep Apnea (OSA). The main objective is to evaluate the accuracy, reliability, and time efficiency of automated scoring algorithms compared to standard manual scoring performed by expert sleep specialists
Read the detailed description
Study Procedures
- Pre-PSG Assessment: Demographic data, anthropometric measurements (weight, height, Body mass index (BMI), neck circumference), vital signs, comorbidities, and the STOP-BANG questionnaire are recorded.
- Overnight PSG: Conducted in a sound-attenuated, temperaturecontrolled, well-prepared sleep lab using either SOMNOscreen plus (SOMNOmedics GmbH) or Alice® 6 Sleepware (Philips Respironics, PA, USA). Both systems acquire this channels montage:
- EEG (six channels: F3, F4, C3, C4, O1, O2 referenced to ipsilateral mastoids)
- EOG (two channels: left and right outer canthus)
- Chin EMG (three channels) and anterior tibialis EMG (two channels, bilateral)
- Airflow (oronasal thermistor + nasal pressure transducer cannula)
- ECG (2 leads)
- Body position sensor
- Snoring microphone Respiratory inductive plethysmography (RIP) belts for thoracic and abdominal effort (two channels)
- Pulse oximetry (SpO₂, one channel) via finger probe
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Polysomnographic Scoring (Automated vs. Manual)
- Keywords
- Automated Scoring, Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnographic Scoring (Automated vs. Manual)Diagnostic test
Comparison between automated scoring software and standard manual scoring by expert specialists for sleep study records.
| Study group | Role | What they receive |
|---|---|---|
| Adult OSA Patients | Adult patients diagnosed with Obstructive Sleep Apnea undergoing polysomnography to compare automated versus manual scoring. Receives: Diagnostic Test: Polysomnographic Scoring (Automated vs. Manual) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI) Agreement
Comparison of the Apnea-Hypopnea Index (AHI) values obtained from automated polysomnographic scoring against those obtained from manual scoring.
Measured: At the time of sleep study completion (1 night)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amira Elghonemy, MD candidate, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826143
- Sponsor's protocol ID
- FMASU MD 129/2026
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Versus Manual Polysomnographic Scoring in Adult Patients With Obstructive Sleep Apnea: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT07826143
- Acronym / sponsor ID
- FMASU MD 129/2026
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Automated Scoring, Polysomnography
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Feb 2027 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 17 Sep 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.
This prospective study aims to compare automated polysomnographic scoring with manual scoring in adult patients with Obstructive Sleep Apnea (OSA). The main objective is to evaluate the accuracy, reliability, and time efficiency of automated scoring algorithms compared to standard manual scoring performed by expert sleep specialists
Detailed description
Study Procedures
- Pre-PSG Assessment: Demographic data, anthropometric measurements (weight, height, Body mass index (BMI), neck circumference), vital signs, comorbidities, and the STOP-BANG questionnaire are recorded.
- Overnight PSG: Conducted in a sound-attenuated, temperaturecontrolled, well-prepared sleep lab using either SOMNOscreen plus (SOMNOmedics GmbH) or Alice® 6 Sleepware (Philips Respironics, PA, USA). Both systems acquire this channels montage:
- EEG (six channels: F3, F4, C3, C4, O1, O2 referenced to ipsilateral mastoids)
- EOG (two channels: left and right outer canthus)
- Chin EMG (three channels) and anterior tibialis EMG (two channels, bilateral)
- Airflow (oronasal thermistor + nasal pressure transducer cannula)
- ECG (2 leads)
- Body position sensor
- Snoring microphone Respiratory inductive plethysmography (RIP) belts for thoracic and abdominal effort (two channels)
- Pulse oximetry (SpO₂, one channel) via finger probe
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult OSA Patients | – | Diagnostic Test: Polysomnographic Scoring (Automated vs. Manual)Adult patients diagnosed with Obstructive Sleep Apnea undergoing polysomnography to compare automated versus manual scoring. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the sleep unit with suspected OSA who are scheduled for an overnight diagnostic PSG.
Key inclusion criteria (3 listed)
- Age > 18 years.
- Clinical suspicion of OSA based on history, physical examination, and a positive screening questionnaire (e.g., STOP-BANG ≥ 3).
- Ability to provide written informed consent.
Key exclusion criteria (4 listed)
- Age ≤ 18 years.
- Inability to give informed consent (e.g., severe cognitive impairment, language barrier).
- Contraindications to PSG (e.g., severe skin conditions preventing electrode placement).
- Current use of therapies that could alter sleep architecture (e.g., highdose benzodiazepines, opioids) unless a wash-out period is observed.
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 |
|---|---|---|
| Polysomnographic Scoring (Automated vs. Manual)Comparison between automated scoring software and standard manual scoring by expert specialists for sleep study records. | Diagnostic test | Adult OSA Patients |
Primary outcome
Apnea-Hypopnea Index (AHI) Agreement
Time frame: At the time of sleep study completion (1 night)
Comparison of the Apnea-Hypopnea Index (AHI) values obtained from automated polysomnographic scoring against those obtained from manual scoring.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea
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
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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)
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
Amira Elghonemy, MD candidate principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Ain Shams University at 1 site in Egypt.
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 4 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: opening soon, as of the sponsor's last update on 23 Sep 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Elghonemy, MD Candidate (+201032438035, amiraelghonemy07@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) Agreement (time frame: At the time of sleep study completion (1 night)). 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 23 Sep 2026.