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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name