Obstructive Sleep ApneaVasOSANCT06331819
Clinical Association Between Obstructive Sleep Apnea, Facial Pigmentation, and Vasovagal Symptoms.
An observational study of Obstructive Sleep Apnea and Vasovagal Syncope, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
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 or with an at-home sleep study kit. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea, Vasovagal Syncope, Smoking
- What is being tested?
- In-lab polysomnography, Continuous positive airway pressure and Home sleep study device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteJordan
- Study dates
- 10 Mar 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients within age limit who agree to participate and sign the consent form.
Who cannot join
- Patients with prior diagnosis of obstructive sleep apnea by sleep study.
Trial locations and contacts
1 site in 1 country.
Jordan1 site, 1 recruiting
- Recruiting
The University of Jordan
Amman, 11942
Asma Btoosh, MD, 00962797684137, asmaalbtoosh@gmail.com
Rand M Zaqqa
About this study
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.
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.
Read the 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 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.
- Being tested
- In-lab polysomnography, Continuous positive airway pressure, Home sleep study device
- Keywords
- Obstructive Sleep Apnea, Vasovagal Syncope, Facial Discoloration, Acanthosis Nigricans, Smoking Cessation, Jordan, In-Lab Polysomnography
- Medical subject headings
- Sleep Apnea, Obstructive, Syncope, Vasovagal, Smoking, Acanthosis Nigricans, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-lab polysomnographyDiagnostic test
Also called Sleep study
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
Continuous positive airway pressureDevice
Also called CPAP
A machine that uses air pressure to keep breathing airways open while patients sleep.
Home sleep study deviceDiagnostic test
Patient's brainwaves are recorded overnight to diagnose sleep disorder.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients referred for sleep study by in-lab polysomnography to enrolled hospitals and those provided with an at-home sleep study kit. Receives: Diagnostic Test: In-lab polysomnography; Device: Continuous positive airway pressure; Diagnostic Test: Home sleep study device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start10 Mar 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan Collaborating Cardiology Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rand M Zaqqa, Principal investigator, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331819
- Sponsor's protocol ID
- 7-3-2024
- Acronym
- VasOSA
- Status last verified
- Sep 2024
- First submitted
- 7 Mar 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31300334Bonsignore 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.
PubMed 31694839Eckert 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.
PubMed 19110133White 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.
PubMed 16100008Green 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.
PubMed 34504473Ioannidou 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.
PubMed 34833356Schrand 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.
PubMed 8961240Gozal 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.
PubMed 27166241Soundararajan 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.
PubMed 33767945Tien 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.
PubMed 24586942Jeanmonod R, Sahni D, Silberman M. Vasovagal Episode. 2023 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470277/
PubMed 29262088Puel 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.
PubMed 23623670Willis 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.
PubMed 18772302Tayade 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.
PubMed 23998052
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06331819
- Acronym / sponsor ID
- VasOSA / 7-3-2024
- Keywords
- Obstructive Sleep Apnea, Vasovagal Syncope, Facial Discoloration, Acanthosis Nigricans, Smoking Cessation, Jordan, In-Lab Polysomnography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jordan Collaborating Cardiology GroupUniversity, hospital or other
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Diagnostic Test: In-lab polysomnography, Device: Continuous positive airway pressure, Diagnostic Test: Home sleep study devicePatients referred for sleep study by in-lab polysomnography to enrolled hospitals and those provided with an at-home sleep study kit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients within age limit who agree to participate and sign the consent form.
Key exclusion criteria (1 listed)
- Patients with prior diagnosis of obstructive sleep apnea by sleep study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-lab polysomnographyAlso: Sleep studyPatient's brainwaves are recorded overnight to diagnose sleep disorder. | Diagnostic test | Patients |
| Continuous positive airway pressureAlso: CPAPA machine that uses air pressure to keep breathing airways open while patients sleep. | Device | Patients |
| Home sleep study devicePatient's brainwaves are recorded overnight to diagnose sleep disorder. | Diagnostic test | Patients |
Primary outcome
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 or at-home sleep study and the presence of pigmentation on the face.
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 or at-home sleep study.
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 or at-home sleep study.
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 or at-home sleep study.
3 secondary outcomes
Relation between obstructive sleep apnea and the effect of treatment on facial discolouration
Time frame: 6 months
Relation between obstructive sleep apnea and the effect of treatment on vasovagal symptoms
Time frame: 6 months
Relation between obstructive sleep apnea and the effect of treatment on smoking habits
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 31300334Benjafield 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.
- Background: PubMed 31694839Bonsignore 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.
- Background: PubMed 19110133Eckert 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.
- Background: PubMed 16100008White 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.
- Background: PubMed 34504473Green 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.
- Background: PubMed 34833356Ioannidou 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.
- Background: PubMed 8961240Schrand 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.
- Background: PubMed 27166241Gozal 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.
- Background: PubMed 33767945Soundararajan 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.
- Background: PubMed 24586942Tien 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.
- Background: PubMed 29262088Jeanmonod R, Sahni D, Silberman M. Vasovagal Episode. 2023 Jul 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470277/
- Background: PubMed 23623670Puel 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.
- Individual participant dataSharing planned: Undecided
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rand M Zaqqa principal investigator
Jordan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea and Vasovagal Syncope, run by Jordan Collaborating Cardiology Group at 1 site in Jordan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Jordan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rand M Zaqqa (00962799550746, rand.zaqqa@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical association between obstructive sleep apnea and presence of facial pigmentation (time frame: Immediate after sleep study result). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06331819, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.