Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
16 de junio de 2014 actualizado por: Bangor University
Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.
The purpose of this study is to investigate the correlation between health outcomes associated with the severity of obstructive sleep apnea (OSA) symptomatology, the findings will guide the design of interventional studies.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Obstructive sleep apnea is a condition characterised by periods of narrowing of the pharyngeal airways during sleep causing hypoxic and hypercapnic episodes with the cessation of ventilation.
Considering the high number of overweight and obese individuals in Western society the understanding of the pathomechanisms behind OSA are important.
This observational study aims to investigate the correlations between the severity of Obstructive Sleep Apnea assessed by the apnea-hypopnea index (AHI) and different health outcomes associated with the OSA.
Tipo de estudio
De observación
Inscripción (Actual)
66
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
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Gwynedd
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Bangor, Gwynedd, Reino Unido, LL57 2PW
- Betsi Cadwaladr University Health Board
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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
No
Géneros elegibles para el estudio
Masculino
Método de muestreo
Muestra no probabilística
Población de estudio
Mild to severe recently diagnosed Obstructive Sleep Apnea patients selected by physician who have not received any treatment for their condition.
Selected from Ysbyty Gwynedd in North Wales.
Descripción
Inclusion Criteria:
- Body Mass Index ≤39
- Not received any treatment for Obstructive Sleep Apnea.
- Is a non-smoker
- Is not epileptic
- Epworth Sleepiness Scale ≥ 10.
- Patient's on Statins or antihypertensive drugs are included as so frequent in OSA.
Exclusion Criteria:
- Body Mass Index ≥ 39.
- Presence of significant or unstable Renal, Liver or Heart Failure.
- Receiving anti-diabetic treatment.
- Is a smoker.
- Is epileptic
- Presence of significant or unstable psychological morbidities.
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 |
|---|
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No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Apnea-Hypopnea Index (AHI)
Periodo de tiempo: one night within four weeks of study.
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AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
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one night within four weeks of study.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Residual volume
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
|
Volume of air remaining in lungs after full expiration
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Within four weeks of recruitment prior to CPAP treatment
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Functional residual volume
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Air present in lungs at the end of passive expiration
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Within four weeks of recruitment prior to CPAP treatment
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Total lung capacity
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Total volume of lungs
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Within four weeks of recruitment prior to CPAP treatment
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Forced Vital capacity
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Maximum amount of air which can be expired from the lungs following a full inspiration
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Within four weeks of recruitment prior to CPAP treatment
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Forced expiratory volume in one second (FEV1)
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Maximum amount of air which can be expired from the lungs in one second.
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Within four weeks of recruitment prior to CPAP treatment
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Airway Resistance
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Opposition of flow caused by forces of friction.
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Within four weeks of recruitment prior to CPAP treatment
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Plasma 2-arachidonoylglycerol (2-AG)
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
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Ligand of the G-protein coupled CB1 and CB2 receptors, has been found to be correlated with Oleylethanolamide (OEA) in OSA patients have various effects on energy metabolism.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
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Plasma Anandamide (ANA)
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Ligand of the G-protein coupled CB1 and CB2 receptors, found to be correlated with blood pressure in OSA after the adjustment of confounding variables.
Have various effects on energy metabolism.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma oleoylethanolamine (OEA)
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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A lipid mediator which acts as an anorexigenic (appetite suppressant), and is elevated with sleep deprivation.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Plasma Leptin
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Circulating protein produced in adipose tissue.
Elevated in OSA and obesity.
Leptin may reduce respiratory depression.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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Plasma Adiponectin
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Hormone secreted by adipocytes (Fat cells).
Adiponectin is closely linked to metabolism and may have anti-inflammatory properties.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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Plasma C-reactive Protein
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Marker of inflammation.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Insulin
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Hormone which causes liver and muscle and fat cells to take up glucose to convert to glycogen.
OSA is associated with insulin resistance.
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Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
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Neck circumference
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Waist circumference
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Hip circumference
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Weight
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Within four weeks of recruitment prior to CPAP treatment
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Fat-free mass
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.
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Within four weeks of recruitment prior to CPAP treatment
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Fat mass
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Fat components of the human body estimated non-invasively using bioimpedance measurement system.
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Within four weeks of recruitment prior to CPAP treatment
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Maximal Inspiratory pressure
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
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Within four weeks of recruitment prior to CPAP treatment
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Rate of inspiratory muscle fatigue
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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The decline in maximal inspiratory pressure following inspiration against a resistance.
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Within four weeks of recruitment prior to CPAP treatment
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Chest RPE
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
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Within four weeks of recruitment prior to CPAP treatment
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Dyspnea
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Rating of breathlessness half way through fatigue protocol and at the end of protocol.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 25% O2/ 6% CO2
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Measures the breathing response to high oxygen and high CO2 therefore assessing the central chemoreceptors response only.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 13% O2
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Measures the breathing response to low oxygen.
Designed to Assess the response to the peripheral chemoreceptors.
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Within four weeks of recruitment prior to CPAP treatment
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Ventilation with 13% O2 / 6% CO2
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Measures the breathing response to low oxygen and high CO2.
Designed to assess the response of the sum of the peripheral and central chemoreceptors
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Within four weeks of recruitment prior to CPAP treatment
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Mean RR interval
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: Average time interval between the heart beats R waves
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Within four weeks of recruitment prior to CPAP treatment
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SDNN
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: The standard deviation of all RR intervals
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Within four weeks of recruitment prior to CPAP treatment
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NN50 count
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: The number of pairs of adjacent RR intervals differing by more than 50 ms in the entire analysis interval.
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Within four weeks of recruitment prior to CPAP treatment
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NN50 of total HR (%)
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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Time domain measure: NN50 count divided by total number of all RR intervals.
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Within four weeks of recruitment prior to CPAP treatment
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HRV triangular index
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment
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The total number of RR intervals divided by maximum height of the histogram excluding boundaries.
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Within four weeks of recruitment prior to CPAP treatment
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Low frequency domain
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment.
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Frequency domain analysis: represents 0.04-0.15
Hz reflecting sympathetic activity.
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Within four weeks of recruitment prior to CPAP treatment.
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High frequency domain
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment.
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Frequency domain analysis: represents 0.15-0.40
Hz reflecting parasympathetic activity.
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Within four weeks of recruitment prior to CPAP treatment.
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LF/HF ratio
Periodo de tiempo: Within four weeks of recruitment prior to CPAP treatment.
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The ratio of low frequency (0.04 - 0.15 Hz) to high (0.15-0.40 Hz) frequency recordings.
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Within four weeks of recruitment prior to CPAP treatment.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University
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
1 de noviembre de 2011
Finalización primaria (Actual)
1 de junio de 2014
Finalización del estudio (Actual)
1 de junio de 2014
Fechas de registro del estudio
Enviado por primera vez
24 de noviembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
24 de noviembre de 2011
Publicado por primera vez (Estimar)
29 de noviembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
17 de junio de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
16 de junio de 2014
Última verificación
1 de junio de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- REC No: 11/WNo:01/2
- Earing 11/WNo01/2 (Otro identificador: North West Wales Research Ethics Committee)
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. .