NCT02578303

Brief Summary

Obstructive sleep apnea syndrome (OSAS) is a sleep-disordered breathing characterized by the occurrence of repeated upper airway obstructions leading to airflow reduction (hypopnea) or cessation (apnea). The apnea-hypopnea index (AHI) is the number of apneas and hypopneas per hour of sleep. OSA patients often report cognitive complaints. About 25% of the elderly population is affected by this syndrome with a drastic increase of this rate among dementia patients. OSAS is considered to be an important risk factor for the development of hypertension, heart disease and stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
139

participants targeted

Target at P50-P75 for not_applicable alzheimer-disease

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable alzheimer-disease

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 9, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2015

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

July 14, 2020

Status Verified

July 1, 2019

Enrollment Period

6.7 years

First QC Date

October 9, 2015

Last Update Submit

July 13, 2020

Conditions

Alzheimer Disease

Keywords

sleep apneaphase-contrast MRIcerebral blood flowvascular risk factordementia

Outcome Measures

Primary Outcomes (1)

  • Total arterial flowrate (measured by PC-MRI debit ml/Mn)

    at day 1 after inclusion

Secondary Outcomes (1)

  • sleep apnea measured by elderly polygraphy (Number of apneas / night)

    at day 1 after inclusion up to 24 heures

Study Arms (2)

Dementia group

EXPERIMENTAL

Assessed by the insertion of an interaction parameter between cerebral blood flow and the group label(dementia or no-dementia). ROC method will be used to find a threshold value of IAH that separates the two groups. Interventions: * Vascular flow measurement by PC-MRI * Neuropsychological assessment * Registration of sleep apnea * Registration of blood pressure * ECG holters * Blood test * Geriatric standard evaluation

Other: Vascular flow measurement by PC-MRI

control group

OTHER

Assessed by the insertion of an interaction parameter between cerebral blood flow and the group label(dementia or no-dementia). ROC method will be used to find a threshold value of IAH that separates the two groups. Interventions: * Vascular flow measurement by PC-MRI * Neuropsychological assessment * Registration of sleep apnea * Registration of blood pressure * ECG holters * Blood test * Geriatric standard evaluation

Other: Vascular flow measurement by PC-MRI

Interventions

Vascular flow measurement by PC-MRIOTHER

participants will undergo vascular flow measurement by PC-MRI at intra and extracranial levels

Dementia groupcontrol group

Eligibility Criteria

Age75 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly patients about or over 75 years
  • Any gender
  • Dementia Group:
  • MMSE (Mini Mental State Examination)\> 15
  • Diagnosis of dementia established according to DSM-IV
  • Dementia of the Alzheimer type from NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)
  • Control Group:
  • Preserved cognitive function corresponding to a normal MMSE score by the standards of Poitrenaud
  • Ability to understand and give consent freely (for demented subjects, a legal representative will be delegate)

You may not qualify if:

  • Elderly patients under 75 years
  • Anyone with a classic contraindication to MRI
  • Major behavioral disorders that do not allow the realization of MRI in optimal conditions
  • Claustrophobia
  • Presence of foreign non-compliant material
  • Presence of intraocular metal body
  • Having a history of chest surgery or neurosurgical
  • Chronic respiratory failure
  • Suffering from dementia other than that associated with Alzheimer's disease
  • Patients with a handicap
  • Patients under legal protection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Saint-Quentin

Saint-Quentin, 02100, France

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseSleep Apnea SyndromesDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Study Officials

  • ATTIER Jadwiga, MD

    CH SAINT-QUENTIN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ATTIER Jadwiga, MD

CONTACT

0033323067216j.attier@ch-stquentin.fr

BOULANOPUAR Abdelkrim, CRA

CONTACT

0033323067861a.boulanouar@ch-stquentin.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2015

First Posted

October 16, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

July 14, 2020

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)