NCT05890911

Brief 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). 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jun 2023Dec 2026

First Submitted

Initial submission to the registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

May 25, 2023

Last Update Submit

January 31, 2026

Conditions

Sleep ApneaSleep-Disordered Breathing

Keywords

sleep apneasleep-disordered breathingsleep disorderdopamine

Outcome Measures

Primary Outcomes (1)

  • Relationship between sleep-disordered breathing and blood dopamine level.

    Each participant will undergo blood test focusing on the level of dopamine.

    June 1, 2023 - December 31, 2023

Secondary Outcomes (1)

  • Relationship between sleep-disordered breathing and polymorphism within genes regulating the concentration and encoding receptors of dopamine.

    June 1, 2023 - December 31, 2023

Study Arms (2)

Study group

Participants with the diagnosis of sleep-disordered breathing

Diagnostic Test: PolysomnographyDiagnostic Test: Blood dopamine level measurementDiagnostic Test: Genetical test

Control group

Healthy participants without diagnosis of sleep-disordered breathing

Diagnostic Test: PolysomnographyDiagnostic Test: Blood dopamine level measurementDiagnostic Test: Genetical test

Interventions

PolysomnographyDIAGNOSTIC_TEST

Each of the patients will undergo polysomnography

Control groupStudy group
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).

Control groupStudy group
Blood dopamine level measurementDIAGNOSTIC_TEST

In each of the patients blood dopamine level will be measured

Control groupStudy group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • age between 18 and 80 years old
  • suspicion of sleep-disordered breathing

You may not qualify if:

  • age under 18
  • age over 80
  • severe disorders and systemic diseases (including genetical disorders)
  • neurological disorders
  • active inflammations
  • active cancer
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical Uniwesity

Wroclaw, Poland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Wake Disorders

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Joanna Smardz, Ph.D

    Wroclaw Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 25, 2023

First Posted

June 6, 2023

Study Start

June 1, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations

PL(1)