Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJordan Collaborating Cardiology Group
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients within age limit who agree to participate and sign the consent form.
Disqualifiers
Patients with prior diagnosis of obstructive sleep apnea by sleep study.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
In-lab polysomnography
Diagnostic testPatient's brainwaves are recorded overnight to diagnose sleep disorder.
Continuous positive airway pressure
DeviceA machine that uses air pressure to keep breathing airways open while patients sleep.
Home sleep study device
Diagnostic testPatient's brainwaves are recorded overnight to diagnose sleep disorder.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Patients3 interventions
Trial outcomes
Primary outcomes
1
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 result2
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 result3
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 months4
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 monthsSecondary outcomes
1
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 months2
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 months3
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov