NCT07826143

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
12mo left

Started Feb 2027

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2027

Expected
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 13, 2026

Last Update Submit

September 20, 2026

Conditions

Keywords

Automated ScoringPolysomnography

Outcome Measures

Primary Outcomes (1)

  • Apnea-Hypopnea Index (AHI) Agreement

    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)

Study Arms (1)

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)

Interventions

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

Adult OSA Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain shams university hospitals

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Amira Elghonemy, MD candidate

    Ain Shams University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira Elghonemy, MD Candidate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 17, 2026

Study Start (Estimated)

February 1, 2027

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

September 23, 2026

Record last verified: 2026-09

Locations