Neurocognitive and health-related quality of life outcomes of nocturnal oxygen supply in chronic obstructive pulmonary disease patients with sleep-related oxygen desaturation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95689523

Enrollment

216

Registered

2006-04-11

Start date

2006-03-08

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD with and without nocturnal desaturation Respiratory COPD with and without nocturnal desaturation

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 electroca

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026