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

Obstructive Sleep Apnea Clinical Trial

— VasOSA  

Official title:

Clinical Association Between Obstructive Sleep Apnea (OSA) and Facial Pigmentation, and the Relation Between OSA and Vasovagal Symptoms With Resulting Smoking Tendency and the Effect of Treatment in Patients Referred for Sleep Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331819
• Other study ID #: 7-3-2024
• Status: Recruiting
• Start date: March 10, 2024
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Jordan Collaborating Cardiology Group
• Contact: Rand M Zaqqa
• Phone: 00962799550746
• Email: rand.zaqqa[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. 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.

Description:

In this prospective cohort study, participants referred for a sleep study by in-lab polysomnography at the Jordan University Hospital and those who preferred their study conducted at a private clinic will be screened and physically examined for any facial discoloration which will be accordingly graded as low, moderate, or high based on severity of difference from normal skin colour and texture and pictured with patients' consent and privacy maintained. In addition to a general history, participants will be asked in detail about their smoking habits, vasovagal symptoms, sleeping habits, and any specific obstructive sleep apnea symptoms. After the sleep study is performed, positive and negative results will be collected and correlated with presence of facial discolouration. Severity of OSA will be graded by apnea-hypopnea index (AHI) and recorded as mild (5 - 15 events/hour), moderate (15

• 30 events/hour), or severe (> 30 events/hour). Participants with positive results will then be followed up with at 3 weeks and 6 months to determine what treatment they were given, assessed for improvement on treatment, and be questioned regarding smoking and vasovagal symptoms again. Improvement is defined as better sleep quality and reduction of initial symptoms. Participants with negative results will also be followed up with and asked about their smoking habits and vasovagal symptoms. Correlation will then be made between the group that improved on treatment and the group that did not (whether due to ineffective treatment or not receiving treatment at all) to see if improvement reduces smoking tendency with alleviated vasovagal symptoms, and compared with participants with negative sleep study results for any change in smoking habits as well.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acanthosis Nigricans
• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Smoking
• Syncope
• Syncope, Vasovagal
• Vasovagal Syncope

Intervention

Diagnostic Test:
• In-lab polysomnography
Patient's brainwaves are recorded overnight to diagnose sleep disorder.

Device:
• Continuous positive airway pressure
A machine that uses air pressure to keep breathing airways open while patients sleep.

Locations

Country	Name	City	State
Jordan	The University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Jordan Collaborating Cardiology Group

Country where clinical trial is conducted

Jordan, 

References & 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. — View Citation

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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. — View Citation

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. — View Citation

Jeanmonod R, Sahni D, Silberman M. Vasovagal Episode. 2023 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470277/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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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. Erratum In: J Am Board Fam Med. 2009 Sep-Oct;22(5):596. Shaygan, Ali [added]. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical association between obstructive sleep apnea and presence of facial pigmentation	Number of patients with a confirmed diagnosis of OSA by in-lab polysomnography and the presence of pigmentation on the face.	Immediate after sleep study result
Primary	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.	Immediate after sleep study result
Primary	Relation between obstructive sleep apnea and vasovagal symptoms	Presence of vasovagal symptoms in patients with a confirmed diagnosis of OSA by in-lab polysomnography	6 months
Primary	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	6 months
Secondary	Relation between obstructive sleep apnea and the effect of treatment on facial discolouration	Presence or grade of facial discoloration after patients with a confirmed diagnosis of OSA by in-lab polysomnography receive treatment	6 months
Secondary	Relation between obstructive sleep apnea and the effect of treatment on vasovagal symptoms	Presence of vasovagal symptoms after patients with a confirmed diagnosis of OSA by in-lab polysomnography receive treatment	6 months
Secondary	Relation between obstructive sleep apnea and the effect of treatment on smoking habits	Frequency of smokers after patients with a confirmed diagnosis of OSA by in-lab polysomnography receive treatment	6 months