Nervous System Diseases: Obstructive Sleep Apnoea/Hypopnoea Syndrome Nervous System Diseases Obstructive Sleep Apnoea/Hypopnoea Syndrome
Conditions
Interventions
Each patient will be entered into a four week period during which measurements will made on two occasions in order to allow for habituation to the tests and to cheek that the patients are stable in te
Sponsors
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Eligibility
Inclusion criteria
Inclusion criteria: Research participants will be recruited from those attending a specialist OSAHS clinic based at the Lung Investigation Unit, Queen Elizabeth Hospital. Suitable patients will be identified by the Consultant Clinical Scientist treating the patients at the clinic. The Consultant Clinical Scientist will approach the patients during scheduled clinic visits in order to explain the purpose and nature of the research and to ask for their potential involvement. At this time patients will be given a patient information sheet to read and will be allowed to take this home in order to think about participation and any questions they may have regarding the study requirements and protocol. Following this, interested patients will be asked to return to the department of respiratory medicine for further explanation of the study and to sign a consent form regarding participation. At this time patients will be required to undergo a medical examination in order to ensure that they meet the inclusion/exclusion criteria for participation. Principal inclusion criteria: 1. Patients must be established on CPAP therapy as the aim of the study is to compare usual care with exercise training/dietary intervention 2. Diagnosis of OSAI-IS (SIGN guidelines, 2003): Overweight (BMI>25kg/m2). Patients must be overweight in order to benefit from the exercise training and weight loss programmes. OSAHS that is not attributable to being overweight will not be expected to improve at the end of the programme 3. Evidence of daytime somnolence (Epworth> 10.0). Daytime somnolence is a potentially disabling symptom of OSAHS and would be expected to improve with a reduction in severity of OSAHS 4. Documentation of symptoms such as snoring, cognitive impairment and sleep fragmentation
Exclusion criteria
Exclusion criteria: 1. Unstable heart disease or angina which may pose risks for the performance of exercise 2. Untreated hypothyroidism. This may decrease the effectiveness of a weight loss regime and therefore decrease the validity of the study 3. Severe lung disease. Patients with severe lung disease may be unable to tolerate a high intensity exercise programme and may require ventilation with CPAP despite being of a normal weight. 4. Pregnancy. High intensity exercise and strict dietary modification are not recommended for those who may be pregnant as this may result in damage to the developing foetus. 5. Facial abnormalities. Individuals in which facial abnormalities may contribute to the severity of OSA1~IS would not be expected to benefit from weight loss strategies and may require CPA even when of a normal weight. 6. Eating disorders. Individuals with eating disorders would be unlikely to benefit from the dietary and exercise training programme and should be given help and advice for this problem rather than being recruited to the study 7. Arthritis. Patients with severe arthritis will not be able to perform the exercise training sessions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Lung function, measured via Maximal Flow Volume Curves according to the ARTP/BTS guidelines 2. Exercise capacity, assessed using a maximal incremental cycle ergometer test in order to obtain peak oxygen uptake 3. Endurance exercise capacity, assessed on the cycle ergometer at 80% of the peak exercise achieved on the incremental test During these tests breath by breath measurements of ventilation, oxygen uptake and carbon dioxide output will be obtained and heart rate will be monitored via a 12-lead ECU. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overnight oximetry, performed on two consecutive nights at each time point indicated on the attached schedule. The first night will be performed without the CPAP machine with the second night being performed with the treatment as usual 2. Severity of OSAHS, evaluated using the number or desaturations greater than 4% together with the number of arousals during the night 3. Sleep hygiene, monitored using a sleep diary in which a record will be kept regarding number of hours sleep, awakening, daytime naps and daytime somnolence 4. Health status, assessed using the 36-item short form health survey (SF36), the Epworth Sleepiness Scale and the Hospital Anxiety and Depression (HAD) questionnaire 5. Body composition, measured using bioelectrical impedance analysis (Bodystat 1500) in order to provide an estimate of fat and fat free mass 6. Leptin, homocysteine, insulin, OH and NEFA (Non Esterified Fatty Acids) levels, evaluated using a blood sample and analysed using standard biochemical assays | — |
Countries
United Kingdom
Outcome results
None listed