UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of CPAP treatment adherence using telemedicine in patients with obstructive sleep apnea and survey on changes in consciousness of physical and mental health during "national emergency declaration"
Acronym	Evaluation of CPAP treatment adherence using telemedicine in patients with obstructive sleep apnea and survey on changes in consciousness of physical and mental health during "national emergency declaration"
Scientific Title	Evaluation of CPAP treatment adherence using telemedicine in patients with obstructive sleep apnea and survey on changes in consciousness of physical and mental health during "national emergency declaration"
Scientific Title:Acronym	Evaluation of CPAP treatment adherence using telemedicine in patients with obstructive sleep apnea and survey on changes in consciousness of physical and mental health during "national emergency declaration"
Region	Japan

Condition
Condition	obstructive sleep apnea
Classification by specialty	Pneumology Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate adherence in CPAP treatment using telemedicine in patients with obstructive sleep apnea during "national emergency declaration"
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Number of days of CPAP therapy used per month, hours of use per day
Key secondary outcomes	PSQI score, ESS score, subjective stress, PHQ-2, satisfaction evaluation

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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients who using CPAP therapy for obstructive sleep apnea diagnosed by overnight sleep polysomnography (including home sleep apnea testing), and coming clinic for a face-to-face consultation once a month in outpatient clinics, or face-to-face consultation once every two months with telemedicine. 2. Patients who have been over 3 months since the start of CPAP therapy. 3. Patients who have CPAP treatment during the 4 months prior to enrollment. 4. Patients who used CPAP therapy equipment that allows remote monitoring. Also, th data of remote monitoring include the number of days used and the time used.
Key exclusion criteria	1. Patients who require face-to-face consultation due to complicating disease. 2. Patients who use home oxygen therapy, have difficulty in telemedicine, and have cancer. 3. Patients who have difficulty in filling out questionnaires or teaching by telephone due to cognitive impairment. 4. Other patients who the investigator determined to be inappropriate.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Toshiki Middle name Last name Akahoshi
Organization	Keishinkinenkai
Division name	internal medicine
Zip code	160-0023
Address	6-5-1 Nishishinjuku, Shinjyuku-ku, Tokyo
TEL	03-5909-5588
Email	akahoshi@shinjuku-sleep.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Endo
Organization	Shinjuku Sleep and Respiratory Clinic
Division name	internal medicine
Zip code	160-0023
Address	6-5-1 Nishishinjuku, Shinjyuku-ku, Tokyo
TEL	03-5909-5588
Homepage URL
Email	endo@shinjuku-sleep.jp

Sponsor
Institute	Keishinkinenkai
Institute
Department

Funding Source
Organization	Keishinkinenkai
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Iwata Buddy's Clinic Institutional Review Board
Address	841 Yanaka-machi, Takasaki-shi Gunma
Tel	027-226-5921
Email	sma@ymg-smo.co.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	新宿　睡眠・呼吸器内科クリニック

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 30 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	Open public recruiting
Date of protocol fixation	2020 Year 05 Month 27 Day
Date of IRB	2020 Year 05 Month 27 Day
Anticipated trial start date	2020 Year 05 Month 27 Day
Last follow-up date	2021 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	np

Management information
Registered date	2021 Year 01 Month 29 Day
Last modified on	2021 Year 01 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046333