Assessing the Symptoms of Obstructive Sleep Apnea
OSA
Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study.
2 other identifiers
observational
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2011
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 24, 2011
CompletedFirst Posted
Study publicly available on registry
November 29, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJune 17, 2014
June 1, 2014
2.6 years
November 24, 2011
June 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (34)
Residual volume
Within four weeks of recruitment prior to CPAP treatment
Functional residual volume
Within four weeks of recruitment prior to CPAP treatment
Total lung capacity
Within four weeks of recruitment prior to CPAP treatment
Forced Vital capacity
Within four weeks of recruitment prior to CPAP treatment
Forced expiratory volume in one second (FEV1)
Within four weeks of recruitment prior to CPAP treatment
- +29 more secondary outcomes
Study Arms (1)
No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Betsi Cadwaladr University Health Board
Bangor, Gwynedd, LL57 2PW, United Kingdom
Biospecimen
Blood serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christopher MN Earing, MSc
School of Sport, Health and Exercise Sciences, Bangor University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2011
First Posted
November 29, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 17, 2014
Record last verified: 2014-06