Assessing the Symptoms of Obstructive Sleep Apnea
- Conditions
- Obstructive Sleep Apnea
- Registration Number
- NCT01481636
- Lead Sponsor
- Bangor University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 66
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Apnea-Hypopnea Index (AHI) one night within four weeks of study. AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
- Secondary Outcome Measures
Name Time Method Plasma Adiponectin 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.
Dyspnea Within four weeks of recruitment prior to CPAP treatment Rating of breathlessness half way through fatigue protocol and at the end of protocol.
Waist circumference Within four weeks of recruitment prior to CPAP treatment Plasma 2-arachidonoylglycerol (2-AG) 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.
Residual volume Within four weeks of recruitment prior to CPAP treatment Volume of air remaining in lungs after full expiration
Plasma Anandamide (ANA) 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.
Insulin 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.
Fat mass Within four weeks of recruitment prior to CPAP treatment Fat components of the human body estimated non-invasively using bioimpedance measurement system.
Plasma oleoylethanolamine (OEA) 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.
Plasma C-reactive Protein Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment Marker of inflammation.
Weight Within four weeks of recruitment prior to CPAP treatment Fat-free mass Within four weeks of recruitment prior to CPAP treatment Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.
Chest RPE Within four weeks of recruitment prior to CPAP treatment Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
Ventilation with 25% O2/ 6% CO2 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.
Airway Resistance Within four weeks of recruitment prior to CPAP treatment Opposition of flow caused by forces of friction.
Plasma Leptin 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.
Neck circumference Within four weeks of recruitment prior to CPAP treatment Ventilation with 13% O2 / 6% CO2 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
Mean RR interval Within four weeks of recruitment prior to CPAP treatment Time domain measure: Average time interval between the heart beats R waves
LF/HF ratio 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.
Functional residual volume Within four weeks of recruitment prior to CPAP treatment Air present in lungs at the end of passive expiration
Total lung capacity Within four weeks of recruitment prior to CPAP treatment Total volume of lungs
Forced Vital capacity Within four weeks of recruitment prior to CPAP treatment Maximum amount of air which can be expired from the lungs following a full inspiration
Forced expiratory volume in one second (FEV1) Within four weeks of recruitment prior to CPAP treatment Maximum amount of air which can be expired from the lungs in one second.
Hip circumference Within four weeks of recruitment prior to CPAP treatment Maximal Inspiratory pressure Within four weeks of recruitment prior to CPAP treatment Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
Rate of inspiratory muscle fatigue Within four weeks of recruitment prior to CPAP treatment The decline in maximal inspiratory pressure following inspiration against a resistance.
Ventilation with 13% O2 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.
SDNN Within four weeks of recruitment prior to CPAP treatment Time domain measure: The standard deviation of all RR intervals
Low frequency domain Within four weeks of recruitment prior to CPAP treatment. Frequency domain analysis: represents 0.04-0.15 Hz reflecting sympathetic activity.
High frequency domain Within four weeks of recruitment prior to CPAP treatment. Frequency domain analysis: represents 0.15-0.40 Hz reflecting parasympathetic activity.
NN50 count 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.
NN50 of total HR (%) Within four weeks of recruitment prior to CPAP treatment Time domain measure: NN50 count divided by total number of all RR intervals.
HRV triangular index Within four weeks of recruitment prior to CPAP treatment The total number of RR intervals divided by maximum height of the histogram excluding boundaries.
Trial Locations
- Locations (1)
Betsi Cadwaladr University Health Board
🇬🇧Bangor, Gwynedd, United Kingdom