UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013644 |
|---|---|
| Receipt number | R000015922 |
| Scientific Title | Randomized, sham-controlled, cross-over trial for effects of web-based telemedicine and health-professional aid on PAP adherence in OSA patients |
| Date of disclosure of the study information | 2014/04/05 |
| Last modified on | 2014/04/04 21:37:43 |
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Basic information
Public title
Randomized, sham-controlled, cross-over trial for effects of web-based telemedicine and health-professional aid on PAP adherence in OSA patients
Acronym
Study for judging the effects of active interventions on PAP therapy
Scientific Title
Randomized, sham-controlled, cross-over trial for effects of web-based telemedicine and health-professional aid on PAP adherence in OSA patients
Scientific Title:Acronym
Study for judging the effects of active interventions on PAP therapy
Region
| Japan |
Condition
Condition
Patients with obstructive sleep apnea
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the additional effects of active communications by health professionals appended to web-based telemedicine monitoring on PAP adherence
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The additional effects of active interventions by health professionals appended to web-based telemedicine on PAP adherence during 6-months observation period
Key secondary outcomes
The withdrawal (negative) effects of active interventions by health professionals from web-based telemedicine monitoring on PAP adherence during 6-months observation period
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1) Web-based telemedicine followed by addition of active intervention by health professionals (protocol-1)
2) 2-months observation for each intervention
Interventions/Control_2
1) Combination of web-based telemedicine and active intervention by health professionals followed by removal of health-professional intervention (protocol-2)
2) 2-months observation for each intervention
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with moderate to severe OSA, who continue a stable PAP therapy for at least 2 months after its initiation
Key exclusion criteria
1) Subjects who refused to participate in the study or those who were joining in other studies concurrently advanced in the Center.
2) Subjects who had no abnormal respiration during sleep.
3) Subjects with central sleep apneas.
4) Subjects with any pathological condition, including malignancy in any organ, severe heart failure, heart attack or stroke, renal failure requiring dialysis, or impaired cognitive function.
5) Subjects with mild-to-moderate OSA, to whom the PAP was not introduced.
6) Subjects who had the experience of previous treatment with either PAP or oral appliance.
7) Subjects who had much difficulty in optimal use of PAP device during the two months prior to entry into the study.
8) Subjects whose experience to use PAP was less than two months after initiating PAP therapy.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamaguchi |
Organization
Tokyo Women's Medical University Aoyama Hospital
Division name
Comprehensive Medical Center of Sleep Disorders
Zip code
Address
2-7-13 Kita-Aoyama, Minato-ku, Tokyo 107-0061, Japan
TEL
+81-3-5411-8111
yamaguc@sirius.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Yamaguchi |
Organization
Tokyo Women's Medical University Aoyama Hospital
Division name
Comprehensive Medical Center of Sleep Disorder
Zip code
Address
2-7-13 Kita-Aoyama, Minato-ku, Tokyo 107-0061, Japan
TEL
+81-3-5411-8111
Homepage URL
yamaguc@sirius.ocn.ne.jp
Sponsor or person
Institute
Comprehensive Medical Center of Sleep Disorders
Tokyo Women's Medical University Aoyama Hospital
Institute
Department
Personal name
Funding Source
Organization
Teijin Home Healthcare Limited, Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京女子医科大学附属青山病院（東京都）
Tokyo Women's Medical University Aoyama Hospital, Tokyo, Japan
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1) Web-based telemedicine significantly improved PAP adherence and apnea-related subjective symptoms.
2) Addition of active communication by the health professional does not improve PAP adherence and subjective symptoms further.
3) Withdrawal of active communication by the health professional from web-based telemedicine monitoring does not worsen PAP adherence.
4) The findings mentioned above suggest that web-based telemedicine plays an important role in improving PAP adherence but active communication by the health professional has little impact on improvement of PAP adherence.
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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2014 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015922
