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Investigating the Neuropathology of Obstructive Sleep Apnoea (INcOSA)

8 de octubre de 2019 actualizado por: 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

27

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Reino Unido
      • London, Reino Unido
        • Guy's Hospital Sleep Centre

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 70 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Masculino

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Levels of neuroinflammation, brain morphology and neurophysiology will be measured via MRI, PET-MRI imaging & EEG.
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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.
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

King's College London

Colaboradores

Guy's and St Thomas' NHS Foundation Trust

Investigadores

  • Investigador principal: Ivana Rosenzweig, MD, PhD, King's College London

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de noviembre de 2017

Finalización primaria (Actual)

9 de septiembre de 2019

Finalización del estudio (Actual)

9 de septiembre de 2019

Fechas de registro del estudio

Enviado por primera vez

17 de agosto de 2016

Primero enviado que cumplió con los criterios de control de calidad

15 de noviembre de 2016

Publicado por primera vez (Estimar)

18 de noviembre de 2016

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de octubre de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

8 de octubre de 2019

Última verificación

1 de octubre de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 170912

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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