UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032435 |
|---|---|
| Receipt number | R000036987 |
| Scientific Title | Correlation between chronic idiopathic urticaria and sleep apnea |
| Date of disclosure of the study information | 2018/05/07 |
| Last modified on | 2021/11/04 16:45:34 |
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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
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
nagayama.kisako.up@mail.hosp.go.jp
Sponsor or person
Institute
Clinical Research Center for Allergy and Rheumatology, Sagamihara National Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036987
