|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ ...Back to search results ] | [ Print-friendly version ] |
| Neurocognitive and health-related quality of life outcomes of nocturnal oxygen supply in chronic obstructive pulmonary disease patients with sleep-related oxygen desaturation |
| ISRCTN | ISRCTN95689523 |
| ClinicalTrials.gov identifier | |
| Public title | Neurocognitive and health-related quality of life outcomes of nocturnal oxygen supply in chronic obstructive pulmonary disease patients with sleep-related oxygen desaturation |
| Scientific title | |
| Acronym | GIRON |
| Serial number at source | IAS-PnN1-2006 |
| Study hypothesis | Nocturnal oxygen supply will prevent the consequences of sleep-related hypoxemia (i.e. neurocognitive and health-related quality of life decline) in severe to very severe chronic obstructive pulmonary disease (COPD) patients presenting sleep-related oxygen desaturation. This decline will become similar to that seen in those severe to very severe COPD patients without nocturnal desaturation. |
| Lay summary | |
| Ethics approval | Approved by the Institute of Health Assistance (Institut d'Assistència Sanitària) (IAS), Institutional Review Board (IRB) reviewed the protocol and reported its approval on 27/04/2004, reference number: CEIC-IAS 06/2004 |
| Study design | Prospective, randomised clinical trial and prospective case-control study |
| Countries of recruitment | Spain |
| Disease/condition/study domain | COPD with and without nocturnal desaturation |
| Participants - inclusion criteria |
1. Severe to very severe stable COPD 2. Age 60 to 80 years 3. With a resting awake pO2 between 60 and 80 mmHg, with (cases) or without (controls) sleep-related oxygen desaturation |
| Participants - exclusion criteria |
1. Clinically significant obstructive sleep apnea-hypopnea syndrome2. Alcoholism 3. Anemia 4. Dementia 5. Cirrhosis 6. Obesity 7. Active psychiatric disease 8. Abnormal thyroid function 9. Stroke10. Chronic systemic steroid therapy 11. Malignancy |
| Anticipated start date | 08/03/2006 |
| Anticipated end date | 07/03/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 216 (144 nocturnal desaturators) |
| Interventions | All patients will receive standard care, but nocturnal desaturators will be randomized to receive oxygen during sleep or standard care only. Neurocognitive function, blood/urine analysis and electrocardiogram will be assessed at baseline and at 18 months. Health-related quality of life, lung function, six-minute walking test, nocturnal oxymetry and respiratory and sleep-related symptoms will be assessed at baseline and at six-month intervals. |
| Primary outcome measure(s) |
Neurocognitive function by means of a battery of tests: 1. Trail making test 2. Wechsler adult intelligence scale (WAIS) 3. Wechsler memory scale-revised (WMSR) test 4. Verbal fluency test 5. Rey complex figure test (RCFT) 6. Rey auditory verbal learning test (RAVLT) 7. National adult reading test (NART) 8. Repeatable battery for the assessment of neuropsychological status (RBANS) 9. Luria's premotor test performance |
| Secondary outcome measure(s) |
1. Health-related quality of life (St. George’s respiratory questionnaire) 2. Anxiety (state-trait anxiety inventory [STAI]) 3. Depression (Beck depression inventory [BDI]) 4. Exercise capacity (walking test) 5. Sleepiness (Epworth scale) 6. Dyspnea (Medical Research Council [MRC] scale) 7. Diurnal oxygen and carbonic anhydride blood pressures 8. Nocturnal urinary norepinephrine 9. Exacerbation rate 10. Hospitalization days 11. Mortality |
| Sources of funding |
1. IAS Grants from: 2. Catalan Society of Pneumology 2005 (Societat Catalana de Pneumologia [SOCAP] 2005) 3. Spanish Society of the Pathology of the Respiratory System 2005 (Sociedad Española de Patología del Aparato Respiratorio [SEPAR] 2005) 4. Spanish Company of Air Products and Chemicals Inc. (Sociedad Española de Carburos Metálicos S.A.) |
| Trial website | |
| Publications | |
| Contact name | Dr Susana Mota |
| Address |
Hospital Santa Caterina Hospital de Dia Dr. Castany, s/n |
| City/town | Salt |
| Zip/Postcode | 17019 |
| Country | Spain |
| Tel | +34 (0)97 218 26 00 |
| susana.mota@ias.scs.es | |
| Sponsor | Institute of Health Assistance (Institut d'Assistència Sanitària [IAS]) (Spain) |
| Address |
Parc Hospitalari Marti i Julia Dr. Castany, s/n |
| City/town | Salt |
| Zip/Postcode | 17019 |
| Country | Spain |
| Tel | +34 (0)97 218 26 00 |
| recerca@ias.scs.es | |
| Sponsor website: | http://www.ias.scs.es |
| Date applied | 07/03/2006 |
| Last edited | 11/04/2006 |
| Date ISRCTN assigned | 11/04/2006 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|