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Trial record 3 of 40 for:    osler NOT(osler-rendu) NOT(William Osler) NOT(rendu-osler-weber) NOT(Morbus Osler)

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

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ClinicalTrials.gov Identifier: NCT03290014
Recruitment Status : Recruiting
First Posted : September 21, 2017
Last Update Posted : September 21, 2017
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Brief Summary:

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.


Condition or disease Intervention/treatment
COPD Diagnostic Test: polysomnography Diagnostic Test: Actigraphy Diagnostic Test: Osler test

Study Type : Observational
Estimated Enrollment : 58 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Quality in COPD Patients. A Clinical and Polysomnographic Study
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : September 30, 2018

Group/Cohort Intervention/treatment
Good sleepers
COPD patients with good sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Diagnostic Test: polysomnography
Monitoring of brain activity and respiratory variables during sleep

Diagnostic Test: Actigraphy
monitoring daily physical activity for 7 days

Diagnostic Test: Osler test
Evaluation of subjects´ ability to remain awake
Other Name: Oxford sleep resistance test

Bad sleepers
COPD patients with poor sleep quality according to CASIS score will be studied with polysomnography, actigraphy and OSLER test
Diagnostic Test: polysomnography
Monitoring of brain activity and respiratory variables during sleep

Diagnostic Test: Actigraphy
monitoring daily physical activity for 7 days

Diagnostic Test: Osler test
Evaluation of subjects´ ability to remain awake
Other Name: Oxford sleep resistance test




Primary Outcome Measures :
  1. Sleep efficiency [ Time Frame: One night at the sleep unit ]
    Sleep time/Time in bed


Secondary Outcome Measures :
  1. Total sleep time [ Time Frame: One night at the sleep unit ]
    Total sleep time

  2. Arousal index [ Time Frame: One night at the sleep unit ]
    number of arousals/hour of sleep

  3. sleep architecture [ Time Frame: One night at the sleep unit ]
    percentage of the different sleep phases

  4. Osler test error index [ Time Frame: Next morning after polysomnography (8a.m.--4 p.m.) ]
    number of errors

  5. Actigraphy [ Time Frame: One week previous to polysomnography ]
    Monitoring of rest/activity cycles



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive patients aged 40-80 years, smokers or exsmokers of at least 10 pack-years, diagnosed with moderate-to-severe COPD (post bronchodilator FEV1% < 70% and FEV1 ≥ 30 but < 80% of predicted in a spirometry performed within 6 months prior to inclusion into the study)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290014


Contacts
Contact: Gabriel Sampol, PhD +34932746083 gsampol@vhebron.net
Contact: Jaume Ferrer, PhD +34932746083 jjferrer@vhebron.net

Locations
Spain
Hospital Universitari Vall d´Hebron Recruiting
Barcelona, Spain, 08034
Contact: Gabriel Sampol, PhD    +34932746083    gsampol@vhebron.net   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
AstraZeneca
Investigators
Study Chair: Marc Miravitlles, PhD Vall d´Hebron Institut de Recerca
  Study Documents (Full-Text)

Documents provided by Hospital Universitari Vall d'Hebron Research Institute:
Study Protocol  [PDF] June 10, 2016


Publications:
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT03290014     History of Changes
Other Study ID Numbers: PR(AG)365/2015
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: September 21, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases