An observational study in Obstructive Sleep Apnea, Vasovagal Syncope and Smoking, sponsored by Jordan Collaborating Cardiology Group. Recruiting at 1 site in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Jordan Collaborating Cardiology Group · Observational
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:
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 or with an at-home sleep study kit 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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 200 is above the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Jordan Collaborating Cardiology Group is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
Also known as: Sleep study
A machine that uses air pressure to keep breathing airways open while patients sleep.
Also known as: CPAP
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
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 or at-home sleep study receive treatment
Time frame: 6 months
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 or at-home sleep study receive treatment
Time frame: 6 months
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 or at-home sleep study receive treatment
Time frame: 6 months
Plan to share: Undecided
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Jordan Collaborating Cardiology Group