NCT06326580

Brief Summary

Obstructive sleep apnea syndrome (OSAS)is a sleep breathing disorder manifested by complete apnea or partial hypopnea obstruction of the upper airway, which often remains undiagnosed and untreated (Kuczynski, W., 2019). These episodes, which should be more than 5 per hour and last at least 10 s, can lead to a sleep fragmentation and hypoxia (Huon, L.-K.A., 2017). OSAS predominantly affects 26% of individuals between 30 and 70 years in the U.S (apnea hypopnea index ≥5 events per hour) (Schwartz, M., 2018). Obstructive sleep apnea it is increasingly recognized as an independent risk factor for cardiac, neurologic, and perioperative morbidities. Yet this disorder remains undiagnosed in a substantial portion of our population. It is imperative for all physicians to remain vigilant in identifying patients with signs and symptoms consistent with OSA (Park, J. G., 2011). The test of hypothesis is to design a clinical prediction model of obstructive sleep apnea from collected data of the patients having symptoms of obstructive sleep apnea and the results of their sleep study

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,129

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2024

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

1 year

First QC Date

March 14, 2024

Last Update Submit

March 20, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected.

    The recorded data of all patients which include all their symptoms and comorbidities as well as their use of any regular medications will be collected.

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Egyptian patients in sleep study unit, ChestDepartment Mansoura University Hospital, Egypt

You may qualify if:

  • Patients aged \>18 years old
  • presented with symptoms suggestive of OSA like excessive daytime sleepiness, snoring, nocturnal chocking and witnessed apnea

You may not qualify if:

  • Patients with long-term use of medications known to affect sleep integrity Current
  • alcohol or drug abuse
  • History of psychosis
  • Central sleep apnea syndromes
  • Previous OSA surgery
  • Other sleep disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Dakhlia, 050, Egypt

Location

MeSH Terms

Conditions

Carnevale syndrome

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of chest medicine

Study Record Dates

First Submitted

March 14, 2024

First Posted

March 22, 2024

Study Start

October 20, 2022

Primary Completion

October 20, 2023

Study Completion

February 20, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations