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 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95689523 |
| Secondary identifying numbers | IAS-PnN1-2006 |
- Submission date
- 07/03/2006
- Registration date
- 11/04/2006
- Last edited
- 11/04/2006
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Susana Mota
Scientific
Scientific
Hospital Santa Caterina
Hospital de Dia
Dr. Castany, s/n
Salt
17019
Spain
| Phone | +34 (0)97 218 26 00 |
|---|---|
| susana.mota@ias.scs.es |
Study information
| Study design | Prospective, randomised clinical trial and prospective case-control study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | GIRON |
| Study objectives | 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. |
| Ethics approval(s) | 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 |
| Health condition(s) or problem(s) studied | COPD with and without nocturnal desaturation |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 08/03/2006 |
| Completion date | 07/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 216 (144 nocturnal desaturators) |
| Key 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 |
| Key exclusion criteria | 1. Clinically significant obstructive sleep apnea-hypopnea syndrome 2. Alcoholism 3. Anemia 4. Dementia 5. Cirrhosis 6. Obesity 7. Active psychiatric disease 8. Abnormal thyroid function 9. Stroke 10. Chronic systemic steroid therapy 11. Malignancy |
| Date of first enrolment | 08/03/2006 |
| Date of final enrolment | 07/03/2009 |
Locations
Countries of recruitment
- Spain
Study participating centre
Hospital Santa Caterina
Salt
17019
Spain
17019
Spain
Sponsor information
Institute of Health Assistance (Institut d'Assistència Sanitària [IAS]) (Spain)
Industry
Industry
Parc Hospitalari Marti i Julia
Dr. Castany, s/n
Salt
17019
Spain
| Phone | +34 (0)97 218 26 00 |
|---|---|
| recerca@ias.scs.es | |
| Website | http://www.ias.scs.es |
"ROR" |
https://ror.org/058css875 |
Funders
Funder type
Industry
IAS
No information available
Grants from:
No information available
Catalan Society of Pneumology 2005 (Societat Catalana de Pneumologia [SOCAP] 2005)
No information available
Spanish Society of the Pathology of the Respiratory System 2005 (Sociedad Española de Patología del Aparato Respiratorio [SEPAR] 2005)
No information available
Spanish Company of Air Products and Chemicals Inc. (Sociedad Española de Carburos Metálicos S.A.)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
