UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014154
Receipt number R000016479
Scientific Title Clinical research on Sleep Disorders in Primary Headache Patients
Date of disclosure of the study information 2014/07/01
Last modified on 2016/03/25 09:32:51

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Basic information

Public title

Clinical research on Sleep Disorders in Primary Headache Patients

Acronym

SDPH

Scientific Title

Clinical research on Sleep Disorders in Primary Headache Patients

Scientific Title:Acronym

SDPH

Region

Japan


Condition

Condition

Migraine
Chronic migraine
Tension-type headache
Cluster headache

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We compare sleep disorders among migraine, chronic migraine, tension-type headache and cluster headaache patients.

Basic objectives2

Others

Basic objectives -Others

Sleep disorders and nightmares have been reported in migraine patients, which may suggest the involvement of rapid eye movement (REM) sleep regulation in migraine. However, the relationship between migraine and REM sleep behaviour disorder (RBD) remains unclear.Therefore, we explore RBD in primary headache patients.

Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Total score of below scales in primary headache patients.
#1. Pittsburgh Sleep Quality Index
#2. Epworth Sleepiness Scale
#3. RBD screening questionnaires

Key secondary outcomes

Total score of below scales in primary headache patients.
#1. Headache Impact Test-6 (Japanese version)


Base

Study type


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

5

Purpose of intervention

Prevention

Type of intervention

Device,equipment Other

Interventions/Control_1

Headache Impact Test-6 (Japanese version)

Interventions/Control_2

RDB Screening Questionnaires

Interventions/Control_3

Pittsburgh Sleep Quality Index

Interventions/Control_4

Epworth Sleepiness Scale

Interventions/Control_5

Measurement the ratio of REM sleep using the sleep scan

Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Headache patients, who are attending the neurology outpatient clinic in the Keio University hospital, obtained the informed consent and fulfilled the diagnositic criteria of the international headache society, are included in this study .

Key exclusion criteria

Headache patients, who are attending the neurology outpatient clinic in the Keio University hospital and not obtained the informed consent, are excluded in this study .

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Norihiro Suzuki

Organization

School of Medicine, Keio University

Division name

Department of Neurology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3787

Email

nrsuzuki@a2.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshihiko Shimizu

Organization

School of Medicine, Keio University

Division name

Department of Neurology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3788

Homepage URL


Email

shimizu-toshi@umin.ac.jp


Sponsor or person

Institute

Department of Neurology, School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2014 Year 07 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


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Terminated

Date of protocol fixation

2014 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 07 Month 01 Day

Last follow-up date

2016 Year 03 Month 01 Day

Date of closure to data entry

2016 Year 03 Month 01 Day

Date trial data considered complete

2016 Year 03 Month 01 Day

Date analysis concluded

2016 Year 03 Month 01 Day


Other

Other related information



Management information

Registered date

2014 Year 06 Month 03 Day

Last modified on

2016 Year 03 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016479


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name