UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041521 |
|---|---|
| Receipt number | R000047003 |
| Scientific Title | Characteristics of subjective and objective sleep indices in adult ADHD with sleep disorders |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2022/12/12 22:53:01 |
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Basic information
Public title
Characteristics of subjective and objective sleep indices in adult ADHD with sleep disorders
Acronym
Characteristics of subjective and objective sleep indices in adult ADHD with sleep disorders
Scientific Title
Characteristics of subjective and objective sleep indices in adult ADHD with sleep disorders
Scientific Title:Acronym
Characteristics of subjective and objective sleep indices in adult ADHD with sleep disorders
Region
| Japan |
Condition
Condition
Attention deficit hyperactivity disorder
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the characteristics of subjective and objective evaluations in patients with sleep-tested adult ADHD.
Basic objectives2
Others
Basic objectives -Others
To clarify the relationship between sleep index and mental scale in patients diagnosed with adult ADHD in patients with sleep-tested adult ADHD.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total sleep time, sleep latency, number of stage changes, PSQI, ISI-J
Key secondary outcomes
ASRS BDI-II, AQ-J-10, MEQ, MSLT index, actigram index
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a history of Kurume University Department of Psychiatry and Sleep Outpatients from April 1, 2010 to March 31, 2020.
Age 18 or older.
ASRS A part total score is 4 points or more at the first visit.
Enforcement of PSG test at Kurume University.
Key exclusion criteria
Under 18.
Complication of serious mental or physical illness.
PSG data is missing.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Naohisa |
| Middle name | |
| Last name | Uchimura |
Organization
Kurume University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
830-0011
Address
67 Asahi-cho, Kurume-shi, Fukuoka
TEL
0942-31-7564
naohisa@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Kato |
Organization
Kurume University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
830-0011
Address
67 Asahi-cho, Kurume-shi, Fukuoka
TEL
0942-31-7564
Homepage URL
katou_takao@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
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
Kurume University Hospital Industry-academia-government collaboration
Address
67 Asahi-cho, Kurume-shi, Fukuoka
Tel
0942-31-7917
i_rinri@kurume-u.ac.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
170
Results
1) The scores of Epworth Sleepiness Scale and Pittsburgh Sleep Quality Index C7 were significantly higher.2) In polysomnographic parameters, Wake time After Sleep Onset and Slow Wave Sleep (SWS) time were significantly higher.3) In the ADHD group, there was a significant correlation between SWS time and the score of Epworth Sleepiness Scale.
Results date posted
| 2022 | Year | 08 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
In this retrospective study, a total of 170 patients aged 18 years or older who visited the Sleep Outpatient Clinic at Kurume University Hospital with untreated sleep disorders during the 5-year period from April 2015 to March 2020 were investigated. All patients had undergone PSG and performed a multiple sleep latency test (MSLT) after a 1-week sleep assessment using actigraphy.
Participant flow
The patients medical information was obtained from electronic medical records and interviews with the doctor in charge. First, patients who scored 4 points or higher on part A of the ASRS were extracted among these patients, those who met the DSM5 diagnostic criteria were defined as ADHD, and the others as non ADHD. For subjective measurements, the Japanese version of the Epworth Sleepiness Scale , the Pittsburgh Sleep Quality Index, the Morningness Eveningness Questionnaire Self Assessment, the post PSG sleep questionnaire and the Japanese version of the Insomnia Severity Index were used. For objective measurements, the parameters obtained from PSG, MSLTs, and actigraphy were analyzed. Fourteen patients with missing data for either subjective or objective items were excluded. Furthermore, patients with ADHD related sleep disorders such as central hypersomnia, sleep apnea syndrome with an apnea hypopnea index more than 5, RLS, and periodic limb movement disorder were excluded. Finally, the data of 28 patients with ADHD and 27 with non ADHD were statistically analyzed.
Adverse events
none
Outcome measures
For subjective measurements, the Japanese version of the Epworth Sleepiness Scale (JESS), the Pittsburgh Sleep Quality Index (PSQI), the Morningness Eveningness Questionnaire Self-Assessment (MEQSA), the post-PSG sleep questionnaire , and the Japanese version of the Insomnia Severity Index (ISI J) were used. For objective measurements, the parameters obtained from PSG, MSLTs, and actigraphy were analyzed.
Plan to share IPD
none
IPD sharing Plan description
none
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 08 | Month | 23 | Day |
Last modified on
| 2022 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047003
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/02/25 | 20104研究計画書 最終.docx |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
