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Investigating the Neuropathology of Obstructive Sleep Apnoea (INcOSA)

8. oktober 2019 opdateret af: King's College London

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a cross-sectional physiological study, which is anticipated to last for 4 years. In order to study the mechanism of cognitive dysfunction in Obstructive Sleep Apnoea (OSA), patients will start Continuous Positive Airway Pressure (CPAP) treatment following the confirmed diagnosis of sleep apnoea. CPAP is the treatment of choice for patients with moderate to severe OSA who are sleepy during the day. It is also used in patients with mild OSA if they are excessively sleepy or suffer from cardiovascular risk factors. It is recommended by the National Institute for Clinical Excellence (NICE) as a treatment for adults with moderate or severe OSA (Sleep apnoea - continuous positive airway pressure, NICE 2008). In the proposed study the initiation of CPAP will be within the 18 week period set out in the National Health Service (NHS) Improvement Plan and Standards for Better Health (Standards for Better Health, Department of Health 2004). No patient with a diagnosis of OSA will commence treatment with CPAP later than advised by the NICE guidelines of clinical judgement for the best interest of the patient.

In order to investigate the neuroinflammation process and discrete changes in the brain of patients with OSA, a minimum of 9 patients with mild OSA and 9 patients with severe OSA will be compared to 9 healthy controls following initial sleep (assessment) study. All participants will undergo a dynamic Positron Emission Tomography with Magnetic Resonance Imaging (PET-MR) scan with the Translocator protein (TSPO) tracer [Fluorine-18] N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide (DPA-714) at the time of enrolment to the study. Each participant will also have an MRI scan and cognitive testing.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

27

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

INCLUSION CRITERIA:

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
  • Not professional drivers or shift workers

EXCLUSION CRITERIA:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Levels of neuroinflammation, brain morphology and neurophysiology will be measured via MRI, PET-MRI imaging & EEG.
Tidsramme: 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.
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.
Tidsramme: 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.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
Tidsramme: 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
18 patients, 9 mild & 9 severe.
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

King's College London

Samarbejdspartnere

Guy's and St Thomas' NHS Foundation Trust

Efterforskere

  • Ledende efterforsker: Ivana Rosenzweig, MD, PhD, King's College London

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2017

Primær færdiggørelse (Faktiske)

9. september 2019

Studieafslutning (Faktiske)

9. september 2019

Datoer for studieregistrering

Først indsendt

17. august 2016

Først indsendt, der opfyldte QC-kriterier

15. november 2016

Først opslået (Skøn)

18. november 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 170912

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