Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Assessing the Symptoms of Obstructive Sleep Apnea (OSA)

16 giugno 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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 di studio

Osservativo

Iscrizione (Effettivo)

66

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Regno Unito
    • Gwynedd
      • Bangor, Gwynedd, Regno Unito, LL57 2PW
        • Betsi Cadwaladr University Health Board

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 70 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Maschio

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Apnea-Hypopnea Index (AHI)
Lasso di tempo: 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.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Residual volume
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Within four weeks of recruitment prior to CPAP treatment
Within four weeks of recruitment prior to CPAP treatment
Waist circumference
Lasso di tempo: Within four weeks of recruitment prior to CPAP treatment
Within four weeks of recruitment prior to CPAP treatment
Hip circumference
Lasso di tempo: Within four weeks of recruitment prior to CPAP treatment
Within four weeks of recruitment prior to CPAP treatment
Weight
Lasso di tempo: Within four weeks of recruitment prior to CPAP treatment
Within four weeks of recruitment prior to CPAP treatment
Fat-free mass
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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 (%)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bangor University

Investigatori

  • Investigatore principale: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 novembre 2011

Completamento primario (Effettivo)

1 giugno 2014

Completamento dello studio (Effettivo)

1 giugno 2014

Date di iscrizione allo studio

Primo inviato

24 novembre 2011

Primo inviato che soddisfa i criteri di controllo qualità

24 novembre 2011

Primo Inserito (Stima)

29 novembre 2011

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

17 giugno 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

16 giugno 2014

Ultimo verificato

1 giugno 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • REC No: 11/WNo:01/2
  • Earing 11/WNo01/2 (Altro identificatore: North West Wales Research Ethics Committee)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Apnea ostruttiva del sonno

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Madagascar

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi