臨床研究等提出・公開システム

Date of registration	May. 07, 2021
Last modified on	Feb. 15, 2022
Trial ID	jRCT2032210071

Scientific Title	Sham (software)-controlled, multicenter, dynamic allocation, double-blinded study of non-medication therapy with a software Yukumi in patients with insomnia disorders (verification study)
Public Title	Double-blinded study of non-medication therapy with a software Yukumi in patients with insomnia disorders

Contact for Scientific Queries	Name	Ueno Taro
	Affiliation	SUSMED, Inc
	Address	3-7-2, Nihonbashi-honcho, Chuo-ku, Tokyo
	Telephone	+81-3-6366-7780
	E-mail	support@susmed.co.jp
Contact for Public Queries	Name	Watanabe Yosuke
	Affiliation	SUSMED, Inc
	Address	3-7-2, Nihonbashi-honcho, Chuo-ku, Tokyo
	Telephone	+81-3-6366-7780
	E-mail	support@susmed.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		May. 07, 2021
Actual date of first enrollment		May. 07, 2021
Target sample size		156
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Insomnia disorder (ICSD-3). 2. Patients who can understand Japanese. 3. Patient who has smartphone.
	Exclusion Criteria	1. Patients with Athens Insomnia Scale (AIS) at the getting consent or beginning of the trial less than 9 points. 2. Patients who have experienced drug treatment for insomnia within the past 14 days. 3. Patients without a sleeping diary since 7 days from the start of the trial, or Patients who do not need further improvement. 4. Patients suspected or suffering from the following diseases. Mental illness Sleep apnea syndrome Sleep-related movement disorder Central hypersomnia Accompanying sleep Circadian rhythm disturbance alcoholism drug addiction cancer immune disease 5. Pregnant women, lactating women 6. Patients who are engaged in jobs requiring driving such as automobiles or motorbikes or jobs involving danger or scheduled to participate during the trial participation period.
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Insomnia disorder
Intervention(s)		Patients with insomnia will be provided an active application that provides non-medication therapy or a sham application that excludes the function of non-medication therapy.
Health Condition(s) Keyword		Insomnia disorder
Primary Outcome(s)		Evaluation of Athens Insomnia Scale at 8 weeks from the start of treatment
Secondary Outcome(s)		CGI-I Percentage of patients with AIS of less than 6 points at completion of clinical trial medication after completion of clinical trial

Primary Sponsor	SUSMED, Inc

Name of Certified Review Board	Sone clinic Institutional Review Board
Address	3-32-8, Shinjuku, Shinjuku-ku, Tokyo
Telephone	+81-3-6779-8166
E-Mail	chi-pr-cirb-sone@cmicgroup.com
Approval Status	Approval
Date of approval	April. 01, 2021

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 15, 2022	(this page)	Changes
2	Oct. 27, 2021	Detail	Changes
1	May. 07, 2021	Detail

List of change history