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

March 19, 2024 updated by: Jordan Collaborating Cardiology Group

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Jordan
      • Amman, Jordan, 11942
        • Recruiting
        • The University of Jordan
        • Contact:
        • Principal Investigator:
          • Rand M Zaqqa
        • Principal Investigator:
          • Ayah M Zaqqa, MD
        • Principal Investigator:
          • Maisa Mansoor, MD
        • Principal Investigator:
          • Asma Btoosh, MD
        • Sub-Investigator:
          • Salah Salah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients referred for sleep study by in-lab polysomnography to enrolled hospitals.
Diagnostic test: In-lab polysomnography
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
Other Names:
  • Sleep study
Device: Continuous positive airway pressure
A machine that uses air pressure to keep breathing airways open while patients sleep.
Other Names:
  • CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical association between obstructive sleep apnea and presence of facial pigmentation
Time Frame: Immediate after sleep study result
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
Clinical association between obstructive sleep apnea and severity of facial pigmentation
Time Frame: Immediate after sleep study result
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
Relation between obstructive sleep apnea and vasovagal symptoms
Time Frame: 6 months
Presence of vasovagal symptoms in patients with a confirmed diagnosis of OSA by in-lab polysomnography
6 months
Relation between obstructive sleep apnea and resulting smoking tendency due to vasovagal symptoms
Time Frame: 6 months
Frequency of smokers in patients with a confirmed diagnosis of OSA by in-lab polysomnography
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relation between obstructive sleep apnea and the effect of treatment on facial discolouration
Time Frame: 6 months
Presence or grade of facial discoloration after patients with a confirmed diagnosis of OSA by in-lab polysomnography receive treatment
6 months
Relation between obstructive sleep apnea and the effect of treatment on vasovagal symptoms
Time Frame: 6 months
Presence of vasovagal symptoms after patients with a confirmed diagnosis of OSA by in-lab polysomnography receive treatment
6 months
Relation between obstructive sleep apnea and the effect of treatment on smoking habits
Time Frame: 6 months
Frequency of smokers after patients with a confirmed diagnosis of OSA by in-lab polysomnography receive treatment
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan Collaborating Cardiology Group

Investigators

  • Principal Investigator: Rand M Zaqqa, Jordan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

March 7, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7-3-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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