Assessing the Symptoms of Obstructive Sleep Apnea (OSA)

June 16, 2014 updated by: 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Gwynedd
      • Bangor, Gwynedd, United Kingdom, LL57 2PW
        • Betsi Cadwaladr University Health Board

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Apnea-Hypopnea Index (AHI)
Time Frame: 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.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Residual volume
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Within four weeks of recruitment prior to CPAP treatment
Within four weeks of recruitment prior to CPAP treatment
Waist circumference
Time Frame: Within four weeks of recruitment prior to CPAP treatment
Within four weeks of recruitment prior to CPAP treatment
Hip circumference
Time Frame: Within four weeks of recruitment prior to CPAP treatment
Within four weeks of recruitment prior to CPAP treatment
Weight
Time Frame: Within four weeks of recruitment prior to CPAP treatment
Within four weeks of recruitment prior to CPAP treatment
Fat-free mass
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 (%)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bangor University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher MN Earing, MSc, School of Sport, Health and Exercise Sciences, Bangor University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC No: 11/WNo:01/2
  • Earing 11/WNo01/2 (Other Identifier: North West Wales Research Ethics Committee)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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