UMIN-CTR Clinical Trial

Basic information
Public title	Correlation between chronic idiopathic urticaria and sleep apnea
Acronym	Correlation between chronic idiopathic urticaria and sleep apnea
Scientific Title	Correlation between chronic idiopathic urticaria and sleep apnea
Scientific Title:Acronym	Correlation between chronic idiopathic urticaria and sleep apnea
Region	Japan

Condition
Condition	Chronic idiopathic urticaria / sleep apnea
Classification by specialty	Medicine in general Clinical immunology Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the prevalence of sleep apnea in patients with chronic idiopathic urticaria.
Basic objectives2	Others
Basic objectives -Others	To clarify the prevalence of sleep apnea in patients with chronic idiopathic urticaria.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rate of patients whose AHI(Apnea Hypopnea Index) is more than 5.
Key secondary outcomes	Correlation between the severity of chronic idiopathic urticaria(scored by using weekly urticaria activity score:UAS7) and the severity of sleep apnea(defined as mild(5<=AHI<15), moderate(15<=AHI<20) and severe(30<=AHI)).

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. The age at the time of consent acquisition is 16 years old or more. 2. Persistent symptoms of urticaria for 6 weeks or more. 3. Patients who do not have adequate response to H1-antihistamines. 4. Patients who agree with participation in this research.
Key exclusion criteria	1.The patients whose cause of urticaria is identified. 2.The patients judged as unsuitable for participation by the attending physician.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Kentaro Middle name Last name Watai
Organization	Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Division name	Department of allergy
Zip code	252-0392
Address	18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
TEL	+81-42-742-8311
Email	nagayama.kisako.up@mail.hosp.go.jp

Public contact
Name of contact person	1st name Kisako Middle name Last name Nagayama
Organization	Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Division name	Department of allergy
Zip code	252-0392
Address	18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
TEL	+81-42-742-8311
Homepage URL
Email	nagayama.kisako.up@mail.hosp.go.jp

Sponsor
Institute	Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Institute
Department

Funding Source
Organization	Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Address	18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa 252-0392, Japan
Tel	0427428311
Email	nagayama.kisako.up@mail.hosp.go.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立病院機構相模原病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2018 Year 05 Month 07 Day

Related information
URL releasing protocol	https://www.sciencedirect.com/science/article/pii/S1323893021000897
Publication of results	Published

Result
URL related to results and publications	https://www.sciencedirect.com/science/article/pii/S1323893021000897
Number of participants that the trial has enrolled	37
Results	Of the 37 patients studied, 19 had symptom-free-to-mild CSU (UAS7 <=15) and 18 had moderate-to-severe CSU (UAS7 >=16). The pAHI in the latter group was significantly higher than that in the former group (18 vs. 4.2, p = 0.001). In multivariate logistic analysis, moderate-to-severe SDB (pAHI >=15) was significantly associated with moderate-to-severe CSU even after adjusting for the BMI.
Results date posted	2021 Year 11 Month 04 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	We studied outpatients with CSU who visited the Sagamihara National Hospital allergy department or dermatology department between April 1 and October 31, 2018. The following patients were included: (1) patients aged at least 16 years, (2) patients with persistent urticaria for more than 6 weeks without an eliciting factor, and (3) patients with an inadequate response to histamine H1 receptor antagonist.
Participant flow	All recruited patients were carefully interviewed and examined to ensure that they had no eliciting factors for their urticaria. Supplementary All patients were asked to answer a structured questionnaire regarding their demographics, comorbidity, CSU symptoms, and sleep condition at the time of entry. OCST was performed within 2 weeks of entry. We obtained written informed consent from all participants.
Adverse events	None.
Outcome measures	The UAS7 was used to evaluate for CSU, and the pAHI value was used to evaluate for SDB. The association between SDB and CSU was then evaluated.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2018 Year 03 Month 20 Day
Date of IRB	2018 Year 03 Month 20 Day
Anticipated trial start date	2018 Year 04 Month 30 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry	2020 Year 03 Month 31 Day
Date trial data considered complete	2020 Year 03 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information	height, weight, gender, onset age, disease duration, family history,birth history, comorbid disease, Epworth Sleepiness Scale

Management information
Registered date	2018 Year 04 Month 30 Day
Last modified on	2021 Year 11 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036987