Condition category
Respiratory
Date applied
07/03/2006
Date assigned
11/04/2006
Last edited
11/04/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Susana Mota

ORCID ID

Contact details

Hospital Santa Caterina
Hospital de Dia
Dr. Castany
s/n
Salt
17019
Spain
+34 (0)97 218 26 00
susana.mota@ias.scs.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IAS-PnN1-2006

Study information

Scientific title

Acronym

GIRON

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

08/03/2006

Overall trial end date

07/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

216 (144 nocturnal desaturators)

Participant 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

Recruitment start date

08/03/2006

Recruitment end date

07/03/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital Santa Caterina
Salt
17019
Spain

Sponsor information

Organisation

Institute of Health Assistance (Institut d'Assistència Sanitària [IAS]) (Spain)

Sponsor details

Parc Hospitalari Marti i Julia
Dr. Castany
s/n
Salt
17019
Spain
+34 (0)97 218 26 00
recerca@ias.scs.es

Sponsor type

Industry

Website

http://www.ias.scs.es

Funders

Funder type

Industry

Funder name

IAS

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Grants from:

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Catalan Society of Pneumology 2005 (Societat Catalana de Pneumologia [SOCAP] 2005)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Spanish Society of the Pathology of the Respiratory System 2005 (Sociedad Española de Patología del Aparato Respiratorio [SEPAR] 2005)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Spanish Company of Air Products and Chemicals Inc. (Sociedad Española de Carburos Metálicos S.A.)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes