Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
16. Juni 2014 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
66
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Gwynedd
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Bangor, Gwynedd, Vereinigtes Königreich, LL57 2PW
- Betsi Cadwaladr University Health Board
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 70 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Männlich
Probenahmeverfahren
Nicht-Wahrscheinlichkeitsprobe
Studienpopulation
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.
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
|---|
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No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Apnea-Hypopnea Index (AHI)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Residual volume
Zeitfenster: 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
|
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Functional residual volume
Zeitfenster: 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
|
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Total lung capacity
Zeitfenster: 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
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
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)
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
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
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
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Opposition of flow caused by forces of friction.
|
Within four weeks of recruitment prior to CPAP treatment
|
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Plasma 2-arachidonoylglycerol (2-AG)
Zeitfenster: 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.
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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)
Zeitfenster: 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)
Zeitfenster: 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.
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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
Zeitfenster: 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
|
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Plasma Adiponectin
Zeitfenster: 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
|
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Plasma C-reactive Protein
Zeitfenster: 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
|
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Insulin
Zeitfenster: 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.
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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
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
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Waist circumference
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
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Hip circumference
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
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Weight
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
Within four weeks of recruitment prior to CPAP treatment
|
|
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Fat-free mass
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
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
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
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
Zeitfenster: 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
|
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Rate of inspiratory muscle fatigue
Zeitfenster: 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
|
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Chest RPE
Zeitfenster: Within four weeks of recruitment prior to CPAP treatment
|
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
Zeitfenster: 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
|
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Ventilation with 25% O2/ 6% CO2
Zeitfenster: 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
|
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Ventilation with 13% O2
Zeitfenster: 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
|
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Ventilation with 13% O2 / 6% CO2
Zeitfenster: 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
|
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Mean RR interval
Zeitfenster: 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
|
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SDNN
Zeitfenster: 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
|
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NN50 count
Zeitfenster: 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.
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Within four weeks of recruitment prior to CPAP treatment
|
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NN50 of total HR (%)
Zeitfenster: 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
|
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HRV triangular index
Zeitfenster: 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
|
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Low frequency domain
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. November 2011
Primärer Abschluss (Tatsächlich)
1. Juni 2014
Studienabschluss (Tatsächlich)
1. Juni 2014
Studienanmeldedaten
Zuerst eingereicht
24. November 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. November 2011
Zuerst gepostet (Schätzen)
29. November 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
17. Juni 2014
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. Juni 2014
Zuletzt verifiziert
1. Juni 2014
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- REC No: 11/WNo:01/2
- Earing 11/WNo01/2 (Andere Kennung: North West Wales Research Ethics Committee)
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