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NCT Number: NCT07826143

Automated vs Manual Polysomnography Scoring in Adults With Obstructive Sleep Apnea

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain shams university hospitals

Cairo, Cairo Governorate, Egypt

Location contact

Amira Elghonemy, MD candidate

CONTACT

[email protected]

+201032438035

Amira Elghonemy, MD candidate

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polysomnographic Scoring (Automated vs. Manual)

Diagnostic Test

Comparison between automated scoring software and standard manual scoring by expert specialists for sleep study records.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira Elghonemy, MD Candidate

CONTACT

[email protected]

+201032438035

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Automated Versus Manual Polysomnographic Scoring in Adult Patients With Obstructive Sleep Apnea: A Prospective Comparative Study

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Sep 17, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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