Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms.
NCT ID: NCT06331819
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2024-03-10
2026-03-01
Brief Summary
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* 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.
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Detailed Description
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A purposive sampling technique will be utilized to determine the study population. The target population is patients above the age of 18 referred for sleep study at the Jordan University Hospital and Jordan Hospital. Patients who agree to participate in this study and sign the consent form.
Researchers will interview patients in person at their initial sleep study visit to physically examine and observe participants' faces for discoloration and take pictures for future reference with consent. Follow up at 3 weeks and 6 months will be done either in the clinic or over the phone and Email.
The data will be analysed using frequencies, means, standard deviations, and chi-square tests using SPSS for windows. The chi-square test will be used to assess the significance of the correlation between obstructive sleep apnea and facial discolouration, which will be considered significant at below p\<0.05. Prevalence of vasovagal symptoms as well as smoking habits in patients referred for polysomnography will be recorded and evaluated for significance, and then compared with patients' follow up at 3 weeks and 6 months to assess changes on improvement using the chi-square test as well.
Informed consent will be obtained from participants with anonymity confidentiality assured. The study will be explained to patients, after which they must sign a consent form. Each will be assigned a number and the collected data will be used for analysis without reference to patients' identities. Participation does not add risk to the patients since their treatment plan will not be altered, only followed up with.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Patients referred for sleep study by in-lab polysomnography to enrolled hospitals and those provided with an at-home sleep study kit.
In-lab polysomnography
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
Continuous positive airway pressure
A machine that uses air pressure to keep breathing airways open while patients sleep.
Home sleep study device
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
Interventions
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In-lab polysomnography
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
Continuous positive airway pressure
A machine that uses air pressure to keep breathing airways open while patients sleep.
Home sleep study device
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Jordan Collaborating Cardiology Group
OTHER
Responsible Party
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Principal Investigators
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Rand M Zaqqa
Role: PRINCIPAL_INVESTIGATOR
Jordan University Hospital
Locations
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The University of Jordan
Amman, , Jordan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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/
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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7-3-2024
Identifier Type: -
Identifier Source: org_study_id
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