Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
16 juni 2014 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
66
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Gwynedd
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Bangor, Gwynedd, Verenigd Koninkrijk, LL57 2PW
- Betsi Cadwaladr University Health Board
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
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No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Apnea-Hypopnea Index (AHI)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Residual volume
Tijdsspanne: Within four weeks of recruitment prior to CPAP treatment
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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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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 (%)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 november 2011
Primaire voltooiing (Werkelijk)
1 juni 2014
Studie voltooiing (Werkelijk)
1 juni 2014
Studieregistratiedata
Eerst ingediend
24 november 2011
Eerst ingediend dat voldeed aan de QC-criteria
24 november 2011
Eerst geplaatst (Schatting)
29 november 2011
Updates van studierecords
Laatste update geplaatst (Schatting)
17 juni 2014
Laatste update ingediend die voldeed aan QC-criteria
16 juni 2014
Laatst geverifieerd
1 juni 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- REC No: 11/WNo:01/2
- Earing 11/WNo01/2 (Andere identificatie: North West Wales Research Ethics Committee)
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