Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
16 juin 2014 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
66
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Gwynedd
-
Bangor, Gwynedd, Royaume-Uni, LL57 2PW
- Betsi Cadwaladr University Health Board
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Homme
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
Délai: one night within four weeks of study.
|
AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
|
one night within four weeks of study.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Residual volume
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Volume of air remaining in lungs after full expiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Functional residual volume
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Air present in lungs at the end of passive expiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Total lung capacity
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Total volume of lungs
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Forced Vital capacity
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Maximum amount of air which can be expired from the lungs following a full inspiration
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Forced expiratory volume in one second (FEV1)
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Maximum amount of air which can be expired from the lungs in one second.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Airway Resistance
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Opposition of flow caused by forces of friction.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Plasma 2-arachidonoylglycerol (2-AG)
Délai: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
|
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.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
|
|
Plasma Anandamide (ANA)
Délai: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
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.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma oleoylethanolamine (OEA)
Délai: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
A lipid mediator which acts as an anorexigenic (appetite suppressant), and is elevated with sleep deprivation.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma Leptin
Délai: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Circulating protein produced in adipose tissue.
Elevated in OSA and obesity.
Leptin may reduce respiratory depression.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma Adiponectin
Délai: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Hormone secreted by adipocytes (Fat cells).
Adiponectin is closely linked to metabolism and may have anti-inflammatory properties.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Plasma C-reactive Protein
Délai: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Marker of inflammation.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Insulin
Délai: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
Hormone which causes liver and muscle and fat cells to take up glucose to convert to glycogen.
OSA is associated with insulin resistance.
|
Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
|
|
Neck circumference
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Waist circumference
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Hip circumference
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Weight
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
|
Fat-free mass
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Fat mass
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Fat components of the human body estimated non-invasively using bioimpedance measurement system.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Maximal Inspiratory pressure
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Rate of inspiratory muscle fatigue
Délai: Within four weeks of recruitment prior to CPAP treatment
|
The decline in maximal inspiratory pressure following inspiration against a resistance.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Chest RPE
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Dyspnea
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Rating of breathlessness half way through fatigue protocol and at the end of protocol.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 25% O2/ 6% CO2
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to high oxygen and high CO2 therefore assessing the central chemoreceptors response only.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 13% O2
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to low oxygen.
Designed to Assess the response to the peripheral chemoreceptors.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Ventilation with 13% O2 / 6% CO2
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Measures the breathing response to low oxygen and high CO2.
Designed to assess the response of the sum of the peripheral and central chemoreceptors
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Mean RR interval
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: Average time interval between the heart beats R waves
|
Within four weeks of recruitment prior to CPAP treatment
|
|
SDNN
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: The standard deviation of all RR intervals
|
Within four weeks of recruitment prior to CPAP treatment
|
|
NN50 count
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: The number of pairs of adjacent RR intervals differing by more than 50 ms in the entire analysis interval.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
NN50 of total HR (%)
Délai: Within four weeks of recruitment prior to CPAP treatment
|
Time domain measure: NN50 count divided by total number of all RR intervals.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
HRV triangular index
Délai: Within four weeks of recruitment prior to CPAP treatment
|
The total number of RR intervals divided by maximum height of the histogram excluding boundaries.
|
Within four weeks of recruitment prior to CPAP treatment
|
|
Low frequency domain
Délai: Within four weeks of recruitment prior to CPAP treatment.
|
Frequency domain analysis: represents 0.04-0.15
Hz reflecting sympathetic activity.
|
Within four weeks of recruitment prior to CPAP treatment.
|
|
High frequency domain
Délai: Within four weeks of recruitment prior to CPAP treatment.
|
Frequency domain analysis: represents 0.15-0.40
Hz reflecting parasympathetic activity.
|
Within four weeks of recruitment prior to CPAP treatment.
|
|
LF/HF ratio
Délai: Within four weeks of recruitment prior to CPAP treatment.
|
The ratio of low frequency (0.04 - 0.15 Hz) to high (0.15-0.40 Hz) frequency recordings.
|
Within four weeks of recruitment prior to CPAP treatment.
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 novembre 2011
Achèvement primaire (Réel)
1 juin 2014
Achèvement de l'étude (Réel)
1 juin 2014
Dates d'inscription aux études
Première soumission
24 novembre 2011
Première soumission répondant aux critères de contrôle qualité
24 novembre 2011
Première publication (Estimation)
29 novembre 2011
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 juin 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
16 juin 2014
Dernière vérification
1 juin 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- REC No: 11/WNo:01/2
- Earing 11/WNo01/2 (Autre identifiant: North West Wales Research Ethics Committee)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .