Assessing the Symptoms of Obstructive Sleep Apnea (OSA)
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 24, 2011 | ||||||||
| Last Updated Date | February 18, 2013 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Apnea-Hypopnea Index (AHI) [ Time Frame: one night within four weeks of study. ] [ Designated as safety issue: No ] AHI refers to how is the number of apneas and hypopneas per an hour of sleep. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01481636 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Assessing the Symptoms of Obstructive Sleep Apnea | ||||||||
| Official Title ICMJE | Association of Health Outcomes With Severity of OSA Symptomatology- a Correlation Study. | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: Blood serum |
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| 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. |
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| Condition ICMJE | Obstructive Sleep Apnea | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | No treatment, OSA (AHI >15)
Patients with OSA recruited prior to receiving NHS treatment. |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 77 | ||||||||
| Estimated Completion Date | August 2013 | ||||||||
| Estimated Primary Completion Date | August 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||||||
| Ages | 18 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United Kingdom | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01481636 | ||||||||
| Other Study ID Numbers ICMJE | REC No: 11/WNo:01/2, Earing 11/WNo01/2 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Bangor University | ||||||||
| Study Sponsor ICMJE | Bangor University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Bangor University | ||||||||
| Verification Date | January 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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