Sleep ApneaNCT05890911
The Meaning of Dopaminergic Pathway in Sleep Breathing Disorders.
An observational study of Sleep Apnea and Sleep-Disordered Breathing, run by Wroclaw Medical University at 1 site in Poland.
Trial summary
The participants in the study will be adult patients with suspected sleep-disordered breathing. A one-night polysomnography will be performed using the NOXA1 device (NOX Medical, Reykjavík, Iceland). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Sleep-Disordered Breathing
- What is being tested?
- Polysomnography, Blood dopamine level measurement and Genetical test
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with suspicion of sleep-disordered breathing referred to the Department of Internal Medicine, Occupational Diseases, Hypertension and Clinical Oncology operating at the Wroclaw Medical University. Healthy controls.
Who may be able to join
- age between 18 and 80 years old
- suspicion of sleep-disordered breathing
Who cannot join
- age under 18
- age over 80
- severe disorders and systemic diseases (including genetical disorders)
- neurological disorders
- active inflammations
- active cancer
Show all 13Show fewer
- severe mental disorders and retardation (including genetical)
- taking drugs that could falsify polysomnography
- confirmed alcoholism
- drug addiction
- pregnancy and breast feeding
- treatment using or dependence on any painkillers and/or drugs and substances that may affect nervous, muscular and respiratory system functions
- lack of consent to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Importance of Dopamine and Selected Polymorphisms Within the Genes of the Dopaminergic Pathway in Assessment of the Risk of Development and Severity of Sleep Breathing Disorders.
The participants in the study will be adult patients with suspected sleep-disordered breathing. A one-night polysomnography will be performed using the NOXA1 device (NOX Medical, Reykjavík, Iceland). During the polysomnographic examination, sleep, breathing, heart rate and activity of the masticatory muscles will be recorded. Blood sample will be taken from each of the participants qualified to the study and control group to determine the level of dopamine and used to perform genetic tests of selected single nucleotide polymorphisms occurring within the genes regulating the concentration of dopamine and genes encoding dopamine receptors.
Read the detailed description
Sleep-disordered breathing (SDB) refers to a spectrum of abnormalities related to sleep. Obstructive sleep apnea (OSA) is the most common type of SDB and affects approximately one billion adults worldwide. Untreated OSA leads to significant comorbidities and increased mortality due to significantly increased risk of stroke and heart attack. Because of limited access to objective sleep studies and the fact that untreated OSA is a real risk factor premature death, the determination of possible organic reasons for its occurrence is a key aspect. The purpose of the study is to determine the importance of dopamine levels and selected single nucleotide polymorphisms within genes regulating the concentration of dopamine - the gene responsible for production of the enzyme catechol-O-methyltransferase (COMT) - rs4680 and rs6269 and genes encoding receptors dopamine (DRD1 - rs686, rs5327 and DRD2 - rs1800497) in assessment of the risk of development and advancement of SDB. The participants of the study will be adult patients hospitalized in the Department of Internal Diseases, Occupational Diseases, Hypertension and Clinical Oncology of the Wroclaw Medical University due to suspicion of SDB. One-night polysomnography study will be performed using the NOXA1 device (NOX Medical, Reykjavík, Iceland) at the Sleep Laboratory. During the examination parameters regarding sleep, breathing, heart rate and activity of the masticatory muscles will be recorded. The study group will consist of the participants in whom, on the basis of 3rd edition of the International Classification of Sleep Disorders of the American Academy of Sleep Medicine SDB will be recognized. Control group will consist of healthy participants matched in terms of age and sex. A blood sample will be collected from all participants to determine the level of dopamine and to perform genetic test of selected single nucleotide polymorphisms within the genes regulating the concentration of dopamine - the gene responsible for production the enzyme catechol-O-methyltransferase (COMT) - rs4680 and rs6269 and genes encoding dopamine receptors (DRD1 - rs686, rs5327 and DRD2 - rs1800497). Study group and control group will be compared and the results will be statistically analysed.
- Conditions
- Sleep Apnea, Sleep-Disordered Breathing
- Being tested
- Polysomnography, Blood dopamine level measurement, Genetical test
- Keywords
- sleep apnea, sleep-disordered breathing, sleep disorder, dopamine
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic test
Each of the patients will undergo polysomnography
Blood dopamine level measurementDiagnostic test
In each of the patients blood dopamine level will be measured
Genetical testDiagnostic test
Each of the patients will undergo genetical test focusing on selected single nucleotide polymorphisms within genes regulating the concentration of dopamine - the gene responsible for production of the enzyme catechol-O-methyltransferase (COMT) - rs4680 and rs6269 and genes encoding receptors dopamine (DRD1 - rs686, rs5327 and DRD2 - rs1800497).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Participants with the diagnosis of sleep-disordered breathing Receives: Diagnostic Test: Polysomnography; Diagnostic Test: Blood dopamine level measurement; Diagnostic Test: Genetical test | |
| Control group | Healthy participants without diagnosis of sleep-disordered breathing Receives: Diagnostic Test: Polysomnography; Diagnostic Test: Blood dopamine level measurement; Diagnostic Test: Genetical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between sleep-disordered breathing and blood dopamine level.
Each participant will undergo blood test focusing on the level of dopamine.
Measured: June 1, 2023 - December 31, 2023
Secondary outcomes (3)
Relationship between sleep-disordered breathing and polymorphism within genes regulating the concentration and encoding receptors of dopamine.
Each participant will undergo genetical blood test focusing on the polymorphisms within genes regulating the concentration of dopamine - the gene responsible for production of the enzyme catechol-O-methyltransferase (COMT) - rs4680 and rs6269 and genes encoding receptors dopamine (DRD1 - rs686, rs5327 and DRD2 - rs1800497).
Measured: June 1, 2023 - December 31, 2023
Relationship between sleep bruxism and blood dopamine level.
Each participant will undergo blood test focusing on the level of dopamine.
Measured: June 1, 2023 - December 31, 2023
Relationship between sleep bruxism and polymorphism within genes regulating the concentration and encoding receptors of dopamine.
Each participant will undergo genetical blood test focusing on the polymorphisms within genes regulating the concentration of dopamine - the gene responsible for production of the enzyme catechol-O-methyltransferase (COMT) - rs4680 and rs6269 and genes encoding receptors dopamine (DRD1 - rs686, rs5327 and DRD2 - rs1800497).
Measured: June 1, 2023 - December 31, 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Jun 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Smardz, Wroclaw Medical University
- Investigators
- Joanna Smardz, Ph.D, Principal investigator, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890911
- Sponsor's protocol ID
- WMU2/2023
- Status last verified
- Aug 2026
- First submitted
- 25 May 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Dopamine and Selected Polymorphisms Within the Genes of the Dopaminergic Pathway in Assessment of the Risk of Development and Severity of Sleep Breathing Disorders.
- ClinicalTrials.gov ID
- NCT05890911
- Acronym / sponsor ID
- WMU2/2023
- Conditions
- Sleep Apnea, Sleep-Disordered Breathing
- Keywords
- sleep apnea, sleep-disordered breathing, sleep disorder, dopamine
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 6 Jun 2023 (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 participants in the study will be adult patients with suspected sleep-disordered breathing. A one-night polysomnography will be performed using the NOXA1 device (NOX Medical, Reykjavík, Iceland). During the polysomnographic examination, sleep, breathing, heart rate and activity of the masticatory muscles will be recorded. Blood sample will be taken from each of the participants qualified to the study and control group to determine the level of dopamine and used to perform genetic tests of selected single nucleotide polymorphisms occurring within the genes regulating the concentration of dopamine and genes encoding dopamine receptors.
Detailed description
Sleep-disordered breathing (SDB) refers to a spectrum of abnormalities related to sleep. Obstructive sleep apnea (OSA) is the most common type of SDB and affects approximately one billion adults worldwide. Untreated OSA leads to significant comorbidities and increased mortality due to significantly increased risk of stroke and heart attack. Because of limited access to objective sleep studies and the fact that untreated OSA is a real risk factor premature death, the determination of possible organic reasons for its occurrence is a key aspect. The purpose of the study is to determine the importance of dopamine levels and selected single nucleotide polymorphisms within genes regulating the concentration of dopamine - the gene responsible for production of the enzyme catechol-O-methyltransferase (COMT) - rs4680 and rs6269 and genes encoding receptors dopamine (DRD1 - rs686, rs5327 and DRD2 - rs1800497) in assessment of the risk of development and advancement of SDB. The participants of the study will be adult patients hospitalized in the Department of Internal Diseases, Occupational Diseases, Hypertension and Clinical Oncology of the Wroclaw Medical University due to suspicion of SDB. One-night polysomnography study will be performed using the NOXA1 device (NOX Medical, Reykjavík, Iceland) at the Sleep Laboratory. During the examination parameters regarding sleep, breathing, heart rate and activity of the masticatory muscles will be recorded. The study group will consist of the participants in whom, on the basis of 3rd edition of the International Classification of Sleep Disorders of the American Academy of Sleep Medicine SDB will be recognized. Control group will consist of healthy participants matched in terms of age and sex. A blood sample will be collected from all participants to determine the level of dopamine and to perform genetic test of selected single nucleotide polymorphisms within the genes regulating the concentration of dopamine - the gene responsible for production the enzyme catechol-O-methyltransferase (COMT) - rs4680 and rs6269 and genes encoding dopamine receptors (DRD1 - rs686, rs5327 and DRD2 - rs1800497). Study group and control group will be compared and the results will be statistically analysed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Polysomnography, Diagnostic Test: Blood dopamine level measurement, Diagnostic Test: Genetical testParticipants with the diagnosis of sleep-disordered breathing |
| Control group | – | Diagnostic Test: Polysomnography, Diagnostic Test: Blood dopamine level measurement, Diagnostic Test: Genetical testHealthy participants without diagnosis of sleep-disordered breathing |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of sleep-disordered breathing referred to the Department of Internal Medicine, Occupational Diseases, Hypertension and Clinical Oncology operating at the Wroclaw Medical University. Healthy controls.
Key inclusion criteria (2 listed)
- age between 18 and 80 years old
- suspicion of sleep-disordered breathing
Key exclusion criteria (13 listed)
- age under 18
- age over 80
- severe disorders and systemic diseases (including genetical disorders)
- neurological disorders
- active inflammations
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 |
|---|---|---|
| PolysomnographyEach of the patients will undergo polysomnography | Diagnostic test | Control group, Study group |
| Blood dopamine level measurementIn each of the patients blood dopamine level will be measured | Diagnostic test | Control group, Study group |
| Genetical testEach of the patients will undergo genetical test focusing on selected single nucleotide polymorphisms within genes regulating the concentration of dopamine - the gene responsible for production of the enzyme catechol-O-methyltransferase (COMT) - rs4680 and rs6269 and genes encoding receptors dopamine (DRD1 - rs686, rs5327 and DRD2 - rs1800497). | Diagnostic test | Control group, Study group |
Primary outcome
Relationship between sleep-disordered breathing and blood dopamine level.
Time frame: June 1, 2023 - December 31, 2023
Each participant will undergo blood test focusing on the level of dopamine.
3 secondary outcomes
Relationship between sleep-disordered breathing and polymorphism within genes regulating the concentration and encoding receptors of dopamine.
Time frame: June 1, 2023 - December 31, 2023
Relationship between sleep bruxism and blood dopamine level.
Time frame: June 1, 2023 - December 31, 2023
Relationship between sleep bruxism and polymorphism within genes regulating the concentration and encoding receptors of dopamine.
Time frame: June 1, 2023 - December 31, 2023
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Joanna Smardz, Ph.D principal investigator
Wroclaw Medical University
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 Sleep Apnea and Sleep-Disordered Breathing, run by Wroclaw Medical University at 1 site in Poland.
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 2 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 31 Aug 2026. 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between sleep-disordered breathing and blood dopamine level. (time frame: June 1, 2023 - December 31, 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.