UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043177 |
|---|---|
| Receipt number | R000046333 |
| 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" |
| Date of disclosure of the study information | 2021/01/30 |
| Last modified on | 2021/01/29 15:35:04 |
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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
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
endo@shinjuku-sleep.jp
Sponsor or person
Institute
Keishinkinenkai
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046333
