Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms.

NCT06331819 | Recruiting

• 1 other identifier: 7-3-2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this prospective cohort study is to study patients referred for sleep study by in-lab polysomnography in the Jordan University Hospital and the Jordan Hospital or with an at-home sleep study kit. The main aims are:

• To prospectively obtain demographic and clinical information of patients referred for a sleep study.
• To determine the diagnostic value of facial discoloration as potential marker for obstructive sleep apnea to increase detection rate for the condition.
• To establish a correlation between obstructive sleep apnea and vasovagal symptoms with resulting increased smoking tendency and study the effect of treatment on the disorders.
• To determine the association between timing of appearance of obstructive sleep apnea symptoms and initiation of smoking.

Conditions

Obstructive Sleep Apnea; Vasovagal Syncope; Smoking; Acanthosis Nigricans

Keywords

Obstructive Sleep Apnea; Vasovagal Syncope; Facial Discoloration; Acanthosis Nigricans; Smoking Cessation; Jordan; In-Lab Polysomnography

Outcome Measures

Primary Outcomes (4)

• Clinical association between obstructive sleep apnea and presence of facial pigmentation

  Number of patients with a confirmed diagnosis of OSA by in-lab polysomnography or at-home sleep study and the presence of pigmentation on the face.

  Immediate after sleep study result

• Clinical association between obstructive sleep apnea and severity of facial pigmentation

  Grade of facial pigmentation in comparison with normal skin tone as low, moderate, or high in patients with a confirmed diagnosis of OSA by in-lab polysomnography or at-home sleep study.

  Immediate after sleep study result

• Relation between obstructive sleep apnea and vasovagal symptoms

  Presence of vasovagal symptoms in patients with a confirmed diagnosis of OSA by in-lab polysomnography or at-home sleep study.

  6 months

• Relation between obstructive sleep apnea and resulting smoking tendency due to vasovagal symptoms

  Frequency of smokers in patients with a confirmed diagnosis of OSA by in-lab polysomnography or at-home sleep study.

  6 months

Secondary Outcomes (3)

• Relation between obstructive sleep apnea and the effect of treatment on facial discolouration

  6 months

• Relation between obstructive sleep apnea and the effect of treatment on vasovagal symptoms

  6 months

• Relation between obstructive sleep apnea and the effect of treatment on smoking habits

  6 months

Study Arms (1)

Patients

Patients referred for sleep study by in-lab polysomnography to enrolled hospitals and those provided with an at-home sleep study kit.

Diagnostic Test: In-lab polysomnography; Device: Continuous positive airway pressure; Diagnostic Test: Home sleep study device

Interventions

In-lab polysomnography DIAGNOSTIC_TEST

Patient's brainwaves are recorded overnight to diagnose sleep disorder.

Also known as: Sleep study

Patients

Continuous positive airway pressure DEVICE

A machine that uses air pressure to keep breathing airways open while patients sleep.

Also known as: CPAP

Patients

Home sleep study device DIAGNOSTIC_TEST

Patient's brainwaves are recorded overnight to diagnose sleep disorder.

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population is patients above the age of 18 referred for sleep study at referred hospital. Patients who agree to participate in this study must sign the consent form.

You may qualify if:

• Patients within age limit who agree to participate and sign the consent form.

You may not qualify if:

• Patients with prior diagnosis of obstructive sleep apnea by sleep study.

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead

Study Sites (1)

The University of Jordan

Amman, 11942, Jordan

RECRUITING

Related Publications (14)

• Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

  PMID: 31300334 BACKGROUND

• Bonsignore MR, Saaresranta T, Riha RL. Sex differences in obstructive sleep apnoea. Eur Respir Rev. 2019 Nov 6;28(154):190030. doi: 10.1183/16000617.0030-2019. Print 2019 Dec 31.

  PMID: 31694839 BACKGROUND

• Eckert DJ, Malhotra A, Jordan AS. Mechanisms of apnea. Prog Cardiovasc Dis. 2009 Jan-Feb;51(4):313-23. doi: 10.1016/j.pcad.2008.02.003.

  PMID: 19110133 BACKGROUND

• White DP. Pathogenesis of obstructive and central sleep apnea. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1363-70. doi: 10.1164/rccm.200412-1631SO. Epub 2005 Aug 11.

  PMID: 16100008 BACKGROUND

• Green ME, Bernet V, Cheung J. Thyroid Dysfunction and Sleep Disorders. Front Endocrinol (Lausanne). 2021 Aug 24;12:725829. doi: 10.3389/fendo.2021.725829. eCollection 2021.

  PMID: 34504473 BACKGROUND

• Ioannidou D, Kalamaras G, Kotoulas SC, Pataka A. Smoking and Obstructive Sleep Apnea: Is There An Association between These Cardiometabolic Risk Factors?-Gender Analysis. Medicina (Kaunas). 2021 Oct 20;57(11):1137. doi: 10.3390/medicina57111137.

  PMID: 34833356 BACKGROUND

• Schrand JR. Is sleep apnea a predisposing factor for tobacco use? Med Hypotheses. 1996 Dec;47(6):443-8. doi: 10.1016/s0306-9877(96)90155-3.

  PMID: 8961240 BACKGROUND

• Gozal D, Ham SA, Mokhlesi B. Sleep Apnea and Cancer: Analysis of a Nationwide Population Sample. Sleep. 2016 Aug 1;39(8):1493-500. doi: 10.5665/sleep.6004.

  PMID: 27166241 BACKGROUND

• Soundararajan V, Lor J, Fishbein AB. Sleep Apnea and Skin. Curr Sleep Med Rep. 2020 Sep;6(3):94-100. doi: 10.1007/s40675-020-00179-7. Epub 2020 Aug 25.

  PMID: 33767945 BACKGROUND

• Tien KJ, Chou CW, Lee SY, Yeh NC, Yang CY, Yen FC, Wang JJ, Weng SF. Obstructive sleep apnea and the risk of atopic dermatitis: a population-based case control study. PLoS One. 2014 Feb 25;9(2):e89656. doi: 10.1371/journal.pone.0089656. eCollection 2014.

  PMID: 24586942 BACKGROUND

• Jeanmonod R, Sahni D, Silberman M. Vasovagal Episode. 2023 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470277/

  PMID: 29262088 BACKGROUND

• Puel V, Pepin JL, Gosse P. Sleep related breathing disorders and vasovagal syncope, a possible causal link? Int J Cardiol. 2013 Sep 30;168(2):1666-7. doi: 10.1016/j.ijcard.2013.03.061. Epub 2013 Apr 23. No abstract available.

  PMID: 23623670 BACKGROUND

• Willis FB, Isley AL, Geda YE, Shaygan A, Quarles L 4th, Fredrickson PA. Resolution of syncope with treatment of sleep apnea. J Am Board Fam Med. 2008 Sep-Oct;21(5):466-8. doi: 10.3122/jabfm.2008.05.070274.

  PMID: 18772302 BACKGROUND

• Tayade MC, Kulkarni NB. The effect of smoking on the cardiovascular autonomic functions: a cross sectional study. J Clin Diagn Res. 2013 Jul;7(7):1307-10. doi: 10.7860/JCDR/2013/5526.3133. Epub 2013 Jul 1.

  PMID: 23998052 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Syncope, Vasovagal; Smoking; Acanthosis Nigricans; Smoking Cessation

Interventions

Polysomnography; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Syncope; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Health Behavior

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Rand M Zaqqa

  Jordan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rand M Zaqqa

CONTACT

00962799550746; rand.zaqqa@outlook.com

Ayah M Zaqqa, MD

CONTACT

00962795940252; ayahzaqqa@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 26, 2024
• Study Start: March 10, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

JO (1)