Assessing the Symptoms of Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

— OSA  

Official title:

Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481636
• Other study ID #: REC No: 11/WNo:01/2
• Secondary ID: Earing 11/WNo01/
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: June 16, 2014
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Bangor University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
United Kingdom	Betsi Cadwaladr University Health Board	Bangor	Gwynedd

Sponsors (1)

Lead Sponsor	Collaborator
Bangor University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-Hypopnea Index (AHI)	AHI refers to how is the number of apneas and hypopneas per an hour of sleep.	one night within four weeks of study.	No
Secondary	Residual volume	Volume of air remaining in lungs after full expiration	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Functional residual volume	Air present in lungs at the end of passive expiration	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Total lung capacity	Total volume of lungs	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Forced Vital capacity	Maximum amount of air which can be expired from the lungs following a full inspiration	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Forced expiratory volume in one second (FEV1)	Maximum amount of air which can be expired from the lungs in one second.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Airway Resistance	Opposition of flow caused by forces of friction.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Plasma 2-arachidonoylglycerol (2-AG)	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.	No
Secondary	Plasma Anandamide (ANA)	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	No
Secondary	Plasma oleoylethanolamine (OEA)	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	No
Secondary	Plasma Leptin	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	No
Secondary	Plasma Adiponectin	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	No
Secondary	Plasma C-reactive Protein	Marker of inflammation.	Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment	No
Secondary	Insulin	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	No
Secondary	Neck circumference		Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Waist circumference		Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Hip circumference		Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Weight		Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Fat-free mass	Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Fat mass	Fat components of the human body estimated non-invasively using bioimpedance measurement system.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Maximal Inspiratory pressure	Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Rate of inspiratory muscle fatigue	The decline in maximal inspiratory pressure following inspiration against a resistance.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Chest RPE	Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Dyspnea	Rating of breathlessness half way through fatigue protocol and at the end of protocol.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Ventilation with 25% O2/ 6% CO2	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	No
Secondary	Ventilation with 13% O2	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	No
Secondary	Ventilation with 13% O2 / 6% CO2	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	No
Secondary	Mean RR interval	Time domain measure: Average time interval between the heart beats R waves	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	SDNN	Time domain measure: The standard deviation of all RR intervals	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	NN50 count	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	No
Secondary	NN50 of total HR (%)	Time domain measure: NN50 count divided by total number of all RR intervals.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	HRV triangular index	The total number of RR intervals divided by maximum height of the histogram excluding boundaries.	Within four weeks of recruitment prior to CPAP treatment	No
Secondary	Low frequency domain	Frequency domain analysis: represents 0.04-0.15 Hz reflecting sympathetic activity.	Within four weeks of recruitment prior to CPAP treatment.	No
Secondary	High frequency domain	Frequency domain analysis: represents 0.15-0.40 Hz reflecting parasympathetic activity.	Within four weeks of recruitment prior to CPAP treatment.	No
Secondary	LF/HF ratio	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.	No