Automated vs Manual Polysomnography Scoring in Adults With Obstructive Sleep Apnea

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07826143

Enrollment

Registered

2026-09-17

Start date

2027-02-01

Completion date

2028-02-01

Last updated

2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Automated Scoring, Polysomnography

Brief 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 sleep specialists

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

Interventions

DIAGNOSTIC_TESTPolysomnographic Scoring (Automated vs. Manual)

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Apnea-Hypopnea Index (AHI) Agreement	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.

Countries

Egypt

Contacts

CONTACTAmira Elghonemy, MD Candidate

amiraelghonemy07@gmail.com+201032438035

PRINCIPAL_INVESTIGATORAmira Elghonemy, MD candidate

Ain Shams University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026