TerminatedNot Applicable

Subjective Sleep Quality and Sleep Disorders in Patients With Severe Asthma

Stopped: organization problems

Italy16 participantsStarted 2019-09-10

Plain-language summary

Bronchial asthma is characterized by the presence of symptoms that vary over time and of severity. Asthma symptoms tend to worsen at night and in the early hours of the morning, and the presence of nocturnal symptoms is an important indicator of therapeutic intervention in order to control the severity of the disease. Aim of the study is to investigate sleep disorders and quality, as well as and depressive and anxiety symptoms in patients affected by severe asthma before and after 6 months of treatment with monoclonal therapy. An observational, cohort, prospective, monocentric study will be conducted to evaluate subjective quality of sleep at baseline and post monoclonal treatment.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of severe persistent asthma * Systemic steroids treatment for at least 6 months and/or ≥2 exacerbations in the last year * Need to initiate monoclonal antibody therapy according to guidelines * Age ≥18 years * Signed Informed consent * Patients able to collaborate in the required procedures Exclusion Criteria: * Diagnosis of cognitive impairment

What they're measuring

subjective quality of sleep

Timeframe: 6 months

Trial details

NCT IDNCT04340583

SponsorIstituti Clinici Scientifici Maugeri SpA

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-04-06

View on ClinicalTrials.gov More Asthma trials