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
Protocol serial number	IAS-PnN1-2006
Sponsor	Institute of Health Assistance (Institut d'Assistència Sanitària [IAS]) (Spain)
Funders	IAS, Grants from:, Catalan Society of Pneumology 2005 (Societat Catalana de Pneumologia [SOCAP] 2005), Spanish Society of the Pathology of the Respiratory System 2005 (Sociedad Española de Patología del Aparato Respiratorio [SEPAR] 2005), Spanish Company of Air Products and Chemicals Inc. (Sociedad Española de Carburos Metálicos S.A.)

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

Hospital Santa Caterina
Hospital de Dia
Dr. Castany, s/n
Salt
17019
Spain

Phone	+34 (0)97 218 26 00
Email	susana.mota@ias.scs.es

Study information

Primary study design	Interventional
Study design	Prospective, randomised clinical trial and prospective case-control study
Secondary study design	Randomised controlled trial
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(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
Key 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
Completion date	07/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	216
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan