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

Phase 1

Conditions: Obstructive sleep apnea syndrome
MedDRA version: 21.1Level: LLTClassification code 10055577Term: Obstructive sleep apnea syndromeSystem Organ Class: 100000004855
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2019-003029-83-BE

Lead Sponsor: Service de Neurologie, CHU Liège

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

- Written informed consent.
- Age between 40 and 60 y.
- Severe OSA Syndrome (IAH > 40 and >10% total sleep time with sat <90%.)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary aim of the study is to assess regional brain synaptic density in OSAS patients and to determine whether a significant<br>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 Outcome Measures