Assessing the Symptoms of Obstructive Sleep Apnea

NCT ID: NCT01481636

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-06-30

Brief Summary

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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

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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

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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No treatment, OSA (AHI >15)

Patients with OSA recruited prior to receiving NHS treatment.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bangor University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christopher MN Earing, MSc

Role: PRINCIPAL_INVESTIGATOR

School of Sport, Health and Exercise Sciences, Bangor University

Locations

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Betsi Cadwaladr University Health Board

Bangor, Gwynedd, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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Earing 11/WNo01/2

Identifier Type: OTHER

Identifier Source: secondary_id

REC No: 11/WNo:01/2

Identifier Type: -

Identifier Source: org_study_id

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