UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012639
Receipt number R000014776
Scientific Title The impact of obstructive sleep apnea on resting energy expenditure, sleep duration, and dietary habits: effects of continuous positive airway pressure
Date of disclosure of the study information 2014/03/01
Last modified on 2016/12/13 14:32:51

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Basic information

Public title

The impact of obstructive sleep apnea on resting energy expenditure, sleep duration, and dietary habits: effects of continuous positive airway pressure

Acronym

The impact of obstructive sleep apnea on energy homeostasis

Scientific Title

The impact of obstructive sleep apnea on resting energy expenditure, sleep duration, and dietary habits: effects of continuous positive airway pressure

Scientific Title:Acronym

The impact of obstructive sleep apnea on energy homeostasis

Region

Japan


Condition

Condition

obstructive sleep apnea

Classification by specialty

Pneumology Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Although CPAP treatment does not lead to a significant body weight change in patients with OSA as a whole, some individuals can experience body weight increase or reduction after the initiation of CPAP. Therefore, to explore the potential bidirectional relationship between OSA and obesity, a comprehensive research is needed that examines the effects of CPAP on intraindividual changes in each components of energy homeostasis, including energy expenditure, neurohormonal mediators, sleep duration, and dietary habits.

Basic objectives2

Others

Basic objectives -Others

To explore the causal relationship between obstructive sleep apnea and the factors affecting body weight regulation (resting energy expenditure, sleep duration and dietary habits).

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The change in resting energy expenditure (measured by indirect calorimetry)

Key secondary outcomes

Sleep duration (measured by actigraphy and sleep diary)
Sleep pattern and sleep quality
Energy intake and dietary habits(measured by dietary questionnaire)
Body weight, body composition
Respiratory quotient
Physical activity
Sympathetic activity, cortisol
Satiety/hunger hormones
periostin


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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who are suspected to have obstructive sleep apnea and scheduled to undergo polysomnography.

Key exclusion criteria

1. Current or previous treatments for obstructive sleep apnea
2. Central sleep apnea syndrome
3. Unable to use CPAP
4. Hope for treatments other than CPAP
5. Current or previous treatments (medication or bariatric surgery) for body weight reduction
6. Physically disabled
7. Abnormal thyroid function
8. Long term oxygen therapy
9. Corticosteroids use
10. Hemodialysis
11. Patients with a pacemaker
12. Premenoposal woman

Target sample size

80


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Chin

Organization

Graduate school of medicine, Kyoto University

Division name

Resiratpry care and sleep control medicine

Zip code


Address

Kawahara-cho 54, Shogoin, Sakyo-ku, Kyoto

TEL

075-751-3852

Email

chink@kuhp.kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryo Tachikawa

Organization

Graduate school of medicine, Kyoto University

Division name

Respiratory medicine

Zip code


Address

Shogoin Kawahara-cho 54, Sakyo-ku, Kyoto

TEL

075-751-3852

Homepage URL


Email

ryotkw@gmail.com


Sponsor or person

Institute

Graduate school of medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labor, and Welfare of Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



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

Kyoto University


Other administrative information

Date of disclosure of the study information

2014 Year 03 Month 01 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2014 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2014 Year 02 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete

2015 Year 09 Month 30 Day

Date analysis concluded



Other

Other related information

Prospective observational study

The changes in resting energy expenditure, sleep duration, and dietary habits before and after CPAP treatment will be investigated.

Outcomes will be evaluated at
1) The first PSG for diagnosing OSA (admission)
2) The introduction of CPAP treatment (admission)
3 The follow-up PSG after three months of CPAP treatment (admission)
4. Six months after CPAP treatment (outpatient department, only for body weight and dietary habits)


Management information

Registered date

2013 Year 12 Month 20 Day

Last modified on

2016 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014776


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name