Subjective Sleep Quality and Sleep Disorders in Patients With Severe Asthma

NCT04340583 | Terminated

• 1 other identifier: 2289 CE
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

Sleep disorder; Monoclonal therapy; Anxiety; Depression

Outcome Measures

Primary Outcomes (1)

• subjective quality of sleep

  Pittsburgh Sleep Quality Index score ranging from 0 to 21, where lower scores denote a healthier sleep quality.

  6 months

Secondary Outcomes (7)

• Insomnia

  6 months

• respiratory disorders

  6 months

• circadian rhythm disorders

  6 months

• diurnal sleepiness

  6 months

• anxiety

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referral to medical clinic

You may qualify if:

• 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

You may not qualify if:

• Diagnosis of cognitive impairment

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

Istituti Clinici Maugeri Pneumologia

Tradate, Lombardy, 21049, Italy

Location

Related Publications (3)

• Collomp R, Labsy Z, Zorgati H, Prieur F, Cottin F, Do MC, Gagey O, Lasne F, Collomp K. Therapeutic glucocorticoid administration alters the diurnal pattern of dehydroepiandrosterone. Endocrine. 2014 Aug;46(3):668-71. doi: 10.1007/s12020-013-0122-9. Epub 2013 Dec 18.

  PMID: 24347241 BACKGROUND

• Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, Ortega HG, Pavord ID; SIRIUS Investigators. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014 Sep 25;371(13):1189-97. doi: 10.1056/NEJMoa1403291. Epub 2014 Sep 8.

  PMID: 25199060 BACKGROUND

• Campos FL, de Bruin PFC, Pinto TF, da Silva FGC, Pereira EDB, de Bruin VMS. Depressive symptoms, quality of sleep, and disease control in women with asthma. Sleep Breath. 2017 May;21(2):361-367. doi: 10.1007/s11325-016-1422-0. Epub 2016 Oct 29.

  PMID: 27796717 BACKGROUND

MeSH Terms

Conditions

Asthma; Sleep Wake Disorders; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Antonio Spanevello, Prof

  Istituti Clinici Maugeri

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 9, 2020
• Study Start: September 10, 2019
• Primary Completion: April 6, 2023
• Study Completion: June 5, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-01

Locations

IT (1)