CClinicalTrials.gg
Status unknownNCT02578303VAAPSUpdated Jul 14, 2020

Association Between Cerebral Arterial Vascular Flow and Sleep Apnea in Neurodegenerative Alterations

An interventional study of Vascular flow measurement by PC-MRI in Alzheimer Disease, sponsored by Central Hospital Saint Quentin. Status unknown at 1 site in France. Open to participants aged 75 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-14.

Sponsored by Central Hospital Saint Quentin · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Jul 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
139
Allocation
Non-randomized
Ages
75 Years to 120 Years
Sex
All
01

Study 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.

Read the detailed description

Numerous studies pointed out the close relationship between sleep apnea and cognitive impairment. To the investigators' knowledge, no trials have assessed the existence of a relationship between the IAH index and the cerebral arterial blood flow rate (macrocirculation). Developments in magnetic resonance imaging (MRI) provide new insights into the quantitative study of blood flow through phase contrast MRI also called "flow MRI". The main hypothesis tested in this study is the existence of a relationship between OSAS and total cerebral arterial vascular inflow measured by PC-MRI (in mL/min) in the elderly population.

  • Primary outcome: The apnea/hypopnea index (measured by nocturnal respiratory polygraphy) and total arterial flow rate (measured by PC-MRI)
  • Secondary outcomes:

    1. Measurement of arrhythmia
    2. Measurement of arterial blood pressure
02

Conditions studied

  • Alzheimer Disease

Keywords

  • sleep apnea
  • phase-contrast MRI
  • cerebral blood flow
  • vascular risk factor
  • dementia
03

Who can participate

Ages eligible
75 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Elderly patients about or over 75 years
  2. Any gender
  3. Dementia Group:

    3.1. MMSE (Mini Mental State Examination)> 15

    3.2. Diagnosis of dementia established according to DSM-IV

    3.3. 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)

  4. Control Group:

    Preserved cognitive function corresponding to a normal MMSE score by the standards of Poitrenaud

  5. Ability to understand and give consent freely (for demented subjects, a legal representative will be delegate)

Exclusion criteria

Exclusion Criteria:

  1. Elderly patients under 75 years
  2. Anyone with a classic contraindication to MRI

    2.1 Major behavioral disorders that do not allow the realization of MRI in optimal conditions

    2.2 Claustrophobia

    2.3 Presence of foreign non-compliant material

    2.4 Presence of intraocular metal body

  3. Having a history of chest surgery or neurosurgical
  4. Chronic respiratory failure
  5. Suffering from dementia other than that associated with Alzheimer's disease
  6. Patients with a handicap
  7. Patients under legal protection
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
139 participants (estimated)

Study arms

  • Experimental
    Dementia group

    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

  • Other
    control group

    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

  • OtherVascular flow measurement by PC-MRI

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

05

What researchers measure

Primary outcomes

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

    Time frame: at day 1 after inclusion

Secondary outcomes

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

    Time frame: at day 1 after inclusion up to 24 heures

06

Study locations

1 of 1 sites recruiting
  • CH Saint-Quentin
    Saint-Quentin, 02100, France
    • ATTIER-ZMUDKA Jadwiga, PH · Contact · j.attier@ch-stquentin.fr · 0323067861
    • BOULANOUAR Abdelkrim, CRA · Contact · A.BOULANOUAR@ch-stquentin.fr · 0323067861
    • ATTIER-ZMUDKA MS Jadwiga, PH · Principal investigator
    • DOUADI M Youcef, ph · Sub investigator
    • SOREL ms Claire, ph · Sub investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT02578303
Lead sponsor
Central Hospital Saint Quentin
Responsible party
Sponsor
First posted
Oct 16, 2015
Start date
May 2015
Primary completion
Jan 1, 2022 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Jul 14, 2020

Study contacts

ATTIER Jadwiga, MD
Contact
j.attier@ch-stquentin.fr
0033323067216
BOULANOPUAR Abdelkrim, CRA
Contact
a.boulanouar@ch-stquentin.fr
0033323067861
ATTIER Jadwiga, MD
principal investigator · CH Saint-Quentin

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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