Assessment of changes in regional brain synaptic density in patients with Obstructive Sleep Apnea (OSA) measured by positron emission tomography and 18F-UCB-H.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003029-83-BE

Enrollment

100

Registered

2020-07-06

Start date

2020-12-03

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive sleep apnea syndrome MedDRA version: 21.1 Level: LLT Classification code 10055577 Term: Obstructive sleep apnea syndrome System Organ Class: 100000004855

Interventions

Product Name: [18F]UCB-H Product Code: [18F]UCB-H Pharmaceutical Form: Solution for injection INN or Proposed INN: [18F]UCB-H CAS Number: 1774352-40-7 Other descriptive name: [18F]UCB-H Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent. - Age between 40 and 60 y. - Severe OSA Syndrome (IAH > 40 and >10% total sleep time with sat =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Presence or history of neurological diseases other than MS, psychiatry diseases, major traumatic brain injury, major surgery , uncontrolled infection or medical condition, Female patient without contraception, physical or behavioural state incompatible with the current protocol (including MR compatibility, pregnancy, tutorship or guardianship).

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary aim of the study is to assess regional brain synaptic density in OSAS patients and to determine whether a significant regional decrease in synaptic density can be detected, at the individual level, in comparison to age-matched healthy participants, using PET scanning and [18F]-UCB-H.;Secondary Objective: Not applicable;Primary end point(s): Map of significant regional differences in synaptic density between OSAS patients and normal controls.;Timepoint(s) of evaluation of this end point: Map of significant regional differences in synaptic density between OSAS patients and normal controls	—

Measure

Time frame

Main Objective: The primary aim of the study is to assess regional brain synaptic density in OSAS patients and to determine whether a significant regional decrease in synaptic density can be detected, at the individual level, in comparison to age-matched healthy participants, using PET scanning and [18F]-UCB-H.;Secondary Objective: Not applicable;Primary end point(s): Map of significant regional differences in synaptic density between OSAS patients and normal controls.;Timepoint(s) of evaluation of this end point: Map of significant regional differences in synaptic density between OSAS patients and normal controls

—

Secondary

Measure	Time frame
Secondary end point(s): None;Timepoint(s) of evaluation of this end point: NA	—

Countries

Belgium

Contacts

Public ContactGIGA - CRC in vivo imaging

University of Liège

pmaquet@uliege.be3243662316

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026