Investigating the Neuropathology of Obstructive Sleep Apnoea

NCT02967536 | Completed

• 1 other identifier: 170912
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

Our multi-disciplinary research group works closely with people who have obstructive sleep apnoea. This is a life-long illness that causes breathing to stop during sleep, which leads to low-oxygen in the blood. Breathing restarts when the airway at the back of the throat reopens, usually during arousal from sleep. In some people the repeated arousals from sleep cause daytime sleepiness. Our research has shown that the low blood oxygen levels affect thinking and feeling, and in some cases we think it damages the brain cells involved with memory, attention, emotions and decision-making. This study will investigate the relationship between the amount of oxygen in the blood and the loss (if any) of brain cells. Also how the ability to perform complex tasks is affected in patients that suffer from sleep apnoea. The results will show whether the brain damage in patients with sleep apnoea can be reversed with treatment. These findings will guide doctors in the treatment for sleep apnoea and they will cast light onto the process of memory decline with the aim to preserve brain function.

Conditions

Obstructive Sleep Apnoea; Inflammation

Keywords

cognitive function; microglia; neuroinflammation

Outcome Measures

Primary Outcomes (2)

• Levels of neuroinflammation, brain morphology and neurophysiology will be measured via MRI, PET-MRI imaging & EEG.

  27 participants, 9 healthy controls, 9 mild patients \& 9 severe patients.

  MRI, PET-MRI & EEG data analyses will begin right after the completion of data collection, and the summary of results will be reported as soon as available, expected before the completion date of the study as per IRAS 01/06/2020.

• Cognitive performance using the CANTAB battery.

  27 participants, 9 healthy controls, 9 mild patients \& 9 severe patients.

  Cognitive performance data analyses will be conducted after the completion of data collection, and the summary of results will be reported along the rest of results in the summary that will be published before 01/06/2020.

Secondary Outcomes (1)

• Genetic analysis and linkage to clinical and neuroimaging data will be measured using biological samples (blood or saliva) analysed and stored in the BioResource for Mental and Neurological Health.

  Genetic analysis and linkage to clinical and neuroimaging data analyses are expected to continue after the end of the primary study and they will be independently reported by the BioResource for Mental and Neurological Health KCL, within 5 years of study

Study Arms (3)

Mild OSA

Untreated OSA patients. Apnoea-Hypopnoea Index (AHI) \>5 events/hour and \<10 events/hour with Epworth Sleepiness Score (ESS)\>9.

Severe OSA

Untreated OSA patients. AHI \>30 events/hour, with excessive sleepiness (ESS \>9).

Healthy control

Healthy control. AHI \<5 events/hour.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient group: * Untreated patients with mild Sleep Apnoea - Apnoea-Hypopnoea Index (AHI) \>5 events/hour and \<10 events/hour with excessive sleepiness (Epworth sleepiness score \>9). * Untreated patients with severe Sleep Apnoea - AHI \>30 events/hour with excessive sleepiness (Epworth sleepiness score \>9). Healthy control group: * Male participants * No history of sleep disorders * AHI≤5/hour * No current or previous major neurological or psychiatric disease * Not currently undertaking neuropharmacological treatment * Non-smoker * No history of alcohol or recreational drug abuse, major organ failure * Not professional drivers or shift workers.

You may qualify if:

• Participants with OSA:
• Male patients
• With untreated OSA either mild (AHI≥5/hour and ≤10/hour)
• or severe (AHI≥30/hour)
• With excessive sleepiness (ESS≥9)
• Aged 18-69 years
• Healthy control group:
• Male participants
• No history of sleep disorders
• AHI≤5/hour
• No current or previous major neurological or psychiatric disease
• Not currently undertaking neuropharmacological treatment
• Non-smoker
• No history of alcohol or recreational drug abuse
• No major organ failure

You may not qualify if:

• Having other sleep disorders, neurological or psychiatric disease
• Undertaking neuropharmacological treatment
• Has a history of alcohol or recreational drug abuse, major organ failure
• Professional drivers or shift workers
• Unable to have MR scan (e.g. too heavy (\>200Kg) or have ferromagnetic implants)
• \[18F\]DPA-714 affinity too low
• Inability to comprehend what is proposed
• Inability to travel to the research sites

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Guy's Hospital Sleep Centre

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Participants will be invited to donate samples (blood or saliva) to the Biomedical Research Centre (BRC) Bioresource. In order to have statistical power for genetic analysis, samples from INcOSA participants will need to be combined with those from the OSA BioResource (Research Tissue Bank) volunteers who have provided consented biological samples for future research. These samples may be used for genetic, epigenetic, metabolomic or proteomic analysis.

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Inflammation; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ivana Rosenzweig, MD, PhD

  King's College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: November 18, 2016
• Study Start: November 1, 2017
• Primary Completion: September 9, 2019
• Study Completion: September 9, 2019
• Last Updated: October 10, 2019

Record last verified: 2019-10

Locations

GB (1)