Automated vs Manual Polysomnography Scoring in Adults With Obstructive Sleep Apnea

September 13, 2026 updated by: Ain Shams University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Study Procedures

  1. 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.

  2. 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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Ain Shams University Hospitals
        • Contact:
        • Principal Investigator:
          • Amira Elghonemy, MD candidate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients referred to the sleep unit with suspected OSA who are scheduled for an overnight diagnostic PSG.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Adult OSA Patients
Adult patients diagnosed with Obstructive Sleep Apnea undergoing polysomnography to compare automated versus manual scoring.
Diagnostic test: Polysomnographic Scoring (Automated vs. Manual)
Comparison between automated scoring software and standard manual scoring by expert specialists for sleep study records.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the time of sleep study completion (1 night)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Amira Elghonemy, MD candidate, Ain shams university

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

September 13, 2026

First Submitted That Met QC Criteria

September 13, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 13, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD 129/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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