Role of Biomarkers to Screen for Obstructive Sleep Apnea

NCT04093102 | Unknown

• 1 other identifier: obstructive sleep apnea
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

assess the relationship between obstructive sleep apnea and endocrine, inflammatory, and metabolic bio-markers in consecutively enrolled adult male patients with a clinical suspicion of obstructive sleep apnea.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Validity of biomarkers to screen for obstructive sleep apnea

  analysis of biomarkers results (which include Pentraxin 3, HbA1C,Uric acid,CRP,ESR,Plasma fibrinogen) will be assessed and compared to the results of polysymnography

  baseline

Secondary Outcomes (1)

• Inflammatory biomarker level in OSA patients compared to controls

  baseline

Study Arms (2)

cases

cases with obsrtuctive sleep apnea

Diagnostic Test: biomarkers

control

cases without obstructive sleep apnea.

Diagnostic Test: biomarkers

Interventions

biomarkers DIAGNOSTIC_TEST

bio-markers testing will be made to all suspected OSA patients(CRP, Hba1C,uric acid, ESR, plasma fibrinogen, pentraxin3), and to control cases.

cases; control

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

it will be patients with suspected OSA , bio-markers testing and polysomnography will be done for all participants.

You may qualify if:

• All patients with a clinical suspicion of obstructive sleep apnea enrolled to the investigator's chest department.

You may not qualify if:

• Patients who previously treated as obstructive sleep apnea, or receiving opioid pain medications.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Watson NF. Health Care Savings: The Economic Value of Diagnostic and Therapeutic Care for Obstructive Sleep Apnea. J Clin Sleep Med. 2016 Aug 15;12(8):1075-7. doi: 10.5664/jcsm.6034.

  PMID: 27448424 BACKGROUND

• Kapur V, Blough DK, Sandblom RE, Hert R, de Maine JB, Sullivan SD, Psaty BM. The medical cost of undiagnosed sleep apnea. Sleep. 1999 Sep 15;22(6):749-55. doi: 10.1093/sleep/22.6.749.

  PMID: 10505820 BACKGROUND

• Maeder MT, Mueller C, Schoch OD, Ammann P, Rickli H. Biomarkers of cardiovascular stress in obstructive sleep apnea. Clin Chim Acta. 2016 Sep 1;460:152-63. doi: 10.1016/j.cca.2016.06.046. Epub 2016 Jul 2.

  PMID: 27380998 BACKGROUND

• Montesi SB, Bajwa EK, Malhotra A. Biomarkers of sleep apnea. Chest. 2012 Jul;142(1):239-245. doi: 10.1378/chest.11-2322.

  PMID: 22796846 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Environmental Biomarkers

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Biomarkers; Biological Factors; Biological Phenomena; Environmental Monitoring; Environmental Exposure; Environmental Pollution; Public Health; Environment and Public Health

Study Officials

• suzan salama, professor

  STUDY DIRECTOR

Central Study Contacts

Abuzaid

CONTACT

01064756136; anaover32@yahoo.com

doaa magdy, lecturer

CONTACT

01006261010; doaa_magy2020@yahoo.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: September 17, 2019
• Study Start: October 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 17, 2019

Record last verified: 2019-09