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Sleep Quality in (COPD) Patients (COPD: Chronic Obstructive Pulmonary Disease)

V

Vall d'Hebron University Hospital (HUVH)

Status

Unknown

Conditions

COPD

Treatments

Diagnostic Test: Actigraphy
Diagnostic Test: Osler test
Diagnostic Test: polysomnography

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT03290014
PR(AG)365/2015

Details and patient eligibility

About

Patients with COPD, in addition to daytime symptoms, may suffer from nocturnal disturbances. The frequency of nocturnal problems has been reported to be higher in COPD than in the general population and it currently affects up to 50% of patients.

The CASIS questionnaire includes 7 questions and it has been recently validated as an objective tool to evaluate nocturnal symptoms in patients with asthma and COPD. The present study aims to study the validity of the CASIS questionnaire as a predictor of sleep quality measured by objective polysomnographic parameters.

Enrollment

58 estimated patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with written inform consent to participate in the study and all the following criteria will be selected:

  • Age 40-80 years
  • Smokers or exsmokers of at least 10 pack-years
  • Moderate-to-severe COPD

Exclusion criteria

  • Non-stable COPD. Stability is defined as being exacerbation free and without treatment changes for at least 4 weeks prior to baseline evaluation. The presence of a COPD exacerbation previous to the sleep studies (polysomnography, actigraphy, OSLER test) will lead to an early discontinuation of the patient´s participation in the study.
  • Heart failure, asthma, cancer or other major medical illness with known effects on sleep quality.
  • Unable to understanding the questionnaires administered in the study.
  • Known Obstructive Sleep Apnea, other sleep disorder (narcolepsy, periodic limb movements) or shift work.
  • Chronic respiratory failure (PaO2 <60 mmHg).
  • Treatment with sedatives or antidepressants.

Trial design

58 participants in 2 patient groups

Good sleepers
Description:
COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Treatment:
Diagnostic Test: Osler test
Diagnostic Test: Actigraphy
Diagnostic Test: polysomnography
Bad sleepers
Description:
COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Treatment:
Diagnostic Test: Osler test
Diagnostic Test: Actigraphy
Diagnostic Test: polysomnography

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Gabriel Sampol, PhD; Jaume Ferrer, PhD

Data sourced from clinicaltrials.gov

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