Obstructive Sleep ApneaOSANCT01481636
Assessing the Symptoms of Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Bangor University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2011to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Betsi Cadwaladr University Health Board
Bangor, Gwynedd, LL57 2PW
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, correlation, AHI, symptoms, mechanisms
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment, OSA (AHI >15) | Patients with OSA recruited prior to receiving NHS treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
AHI refers to how is the number of apneas and hypopneas per an hour of sleep.
Measured: one night within four weeks of study.
Secondary outcomes (34)
Residual volume
Volume of air remaining in lungs after full expiration
Measured: Within four weeks of recruitment prior to CPAP treatment
Functional residual volume
Air present in lungs at the end of passive expiration
Measured: Within four weeks of recruitment prior to CPAP treatment
Total lung capacity
Total volume of lungs
Measured: Within four weeks of recruitment prior to CPAP treatment
Forced Vital capacity
Maximum amount of air which can be expired from the lungs following a full inspiration
Measured: Within four weeks of recruitment prior to CPAP treatment
Forced expiratory volume in one second (FEV1)
Maximum amount of air which can be expired from the lungs in one second.
Measured: Within four weeks of recruitment prior to CPAP treatment
Airway Resistance
Opposition of flow caused by forces of friction.
Measured: Within four weeks of recruitment prior to CPAP treatment
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.
Measured: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment.
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.
Measured: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
Plasma oleoylethanolamine (OEA)
A lipid mediator which acts as an anorexigenic (appetite suppressant), and is elevated with sleep deprivation.
Measured: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
Plasma Leptin
Circulating protein produced in adipose tissue. Elevated in OSA and obesity. Leptin may reduce respiratory depression.
Measured: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
Plasma Adiponectin
Hormone secreted by adipocytes (Fat cells). Adiponectin is closely linked to metabolism and may have anti-inflammatory properties.
Measured: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
Plasma C-reactive Protein
Marker of inflammation.
Measured: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
Insulin
Hormone which causes liver and muscle and fat cells to take up glucose to convert to glycogen. OSA is associated with insulin resistance.
Measured: Within four weeks of recruitment prior to CPAP treatment and after four weeks of CPAP treatment
Neck circumference
Measured: Within four weeks of recruitment prior to CPAP treatment
Waist circumference
Measured: Within four weeks of recruitment prior to CPAP treatment
Hip circumference
Measured: Within four weeks of recruitment prior to CPAP treatment
Weight
Measured: Within four weeks of recruitment prior to CPAP treatment
Fat-free mass
Non-fat components of the human body estimated non-invasively using a bioimpedance measurement system.
Measured: Within four weeks of recruitment prior to CPAP treatment
Fat mass
Fat components of the human body estimated non-invasively using bioimpedance measurement system.
Measured: Within four weeks of recruitment prior to CPAP treatment
Maximal Inspiratory pressure
Measured at residual volume, reflects the strength of the diaphragm and other inspiratory muscles.
Measured: Within four weeks of recruitment prior to CPAP treatment
Rate of inspiratory muscle fatigue
The decline in maximal inspiratory pressure following inspiration against a resistance.
Measured: Within four weeks of recruitment prior to CPAP treatment
Chest RPE
Rating of perceived exertion in the chest and associated airways during the inspiratory fatigue protocol.
Measured: Within four weeks of recruitment prior to CPAP treatment
Dyspnea
Rating of breathlessness half way through fatigue protocol and at the end of protocol.
Measured: Within four weeks of recruitment prior to CPAP treatment
Ventilation with 25% O2/ 6% CO2
Measures the breathing response to high oxygen and high CO2 therefore assessing the central chemoreceptors response only.
Measured: Within four weeks of recruitment prior to CPAP treatment
Ventilation with 13% O2
Measures the breathing response to low oxygen. Designed to Assess the response to the peripheral chemoreceptors.
Measured: Within four weeks of recruitment prior to CPAP treatment
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
Measured: Within four weeks of recruitment prior to CPAP treatment
Mean RR interval
Time domain measure: Average time interval between the heart beats R waves
Measured: Within four weeks of recruitment prior to CPAP treatment
SDNN
Time domain measure: The standard deviation of all RR intervals
Measured: Within four weeks of recruitment prior to CPAP treatment
NN50 count
Time domain measure: The number of pairs of adjacent RR intervals differing by more than 50 ms in the entire analysis interval.
Measured: Within four weeks of recruitment prior to CPAP treatment
NN50 of total HR (%)
Time domain measure: NN50 count divided by total number of all RR intervals.
Measured: Within four weeks of recruitment prior to CPAP treatment
HRV triangular index
The total number of RR intervals divided by maximum height of the histogram excluding boundaries.
Measured: Within four weeks of recruitment prior to CPAP treatment
Low frequency domain
Frequency domain analysis: represents 0.04-0.15 Hz reflecting sympathetic activity.
Measured: Within four weeks of recruitment prior to CPAP treatment.
High frequency domain
Frequency domain analysis: represents 0.15-0.40 Hz reflecting parasympathetic activity.
Measured: Within four weeks of recruitment prior to CPAP treatment.
LF/HF ratio
The ratio of low frequency (0.04 - 0.15 Hz) to high (0.15-0.40 Hz) frequency recordings.
Measured: Within four weeks of recruitment prior to CPAP treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangor University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher MN Earing, MSc, Principal investigator, School of Sport, Health and Exercise Sciences, Bangor University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481636
- Sponsor's protocol ID
- REC No: 11/WNo:01/2
- Other IDs
- Earing 11/WNo01/2
- Acronym
- OSA
- Status last verified
- Jun 2014
- First submitted
- 24 Nov 2011
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.
- ClinicalTrials.gov ID
- NCT01481636
- Acronym / sponsor ID
- OSA / REC No: 11/WNo:01/2
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive sleep apnea, correlation, AHI, symptoms, mechanisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Bangor UniversityUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment, OSA (AHI >15) | – | –Patients with OSA recruited prior to receiving NHS treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Body Mass Index ≤39
- Not received any treatment for Obstructive Sleep Apnea.
- Is a non-smoker
- Is not epileptic
- Epworth Sleepiness Scale ≥ 10.
Key exclusion criteria (6 listed)
- Body Mass Index ≥ 39.
- Presence of significant or unstable Renal, Liver or Heart Failure.
- Receiving anti-diabetic treatment.
- Is a smoker.
- Is epileptic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
34 secondary outcomes
Residual volume
Time frame: Within four weeks of recruitment prior to CPAP treatment
Functional residual volume
Time frame: Within four weeks of recruitment prior to CPAP treatment
Total lung capacity
Time frame: Within four weeks of recruitment prior to CPAP treatment
Forced Vital capacity
Time frame: 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
Airway Resistance
Time frame: 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.
Plasma Anandamide (ANA)
Time frame: 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
Plasma Leptin
Time frame: 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
Plasma C-reactive Protein
Time frame: 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
Neck circumference
Time frame: Within four weeks of recruitment prior to CPAP treatment
Waist circumference
Time frame: Within four weeks of recruitment prior to CPAP treatment
Hip circumference
Time frame: Within four weeks of recruitment prior to CPAP treatment
Weight
Time frame: Within four weeks of recruitment prior to CPAP treatment
Fat-free mass
Time frame: Within four weeks of recruitment prior to CPAP treatment
Fat mass
Time frame: Within four weeks of recruitment prior to CPAP treatment
Maximal Inspiratory pressure
Time frame: 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
Chest RPE
Time frame: Within four weeks of recruitment prior to CPAP treatment
Dyspnea
Time frame: 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
Ventilation with 13% O2
Time frame: 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
Mean RR interval
Time frame: Within four weeks of recruitment prior to CPAP treatment
SDNN
Time frame: Within four weeks of recruitment prior to CPAP treatment
NN50 count
Time frame: Within four weeks of recruitment prior to CPAP treatment
NN50 of total HR (%)
Time frame: Within four weeks of recruitment prior to CPAP treatment
HRV triangular index
Time frame: Within four weeks of recruitment prior to CPAP treatment
Low frequency domain
Time frame: Within four weeks of recruitment prior to CPAP treatment.
High frequency domain
Time frame: Within four weeks of recruitment prior to CPAP treatment.
LF/HF ratio
Time frame: Within four weeks of recruitment prior to CPAP treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher MN Earing, MSc principal investigator
School of Sport, Health and Exercise Sciences, Bangor University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Bangor University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (AHI) (time frame: one night within four weeks of study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.