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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012639
Receipt No. 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

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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
Institute Graduate school of medicine, Kyoto University
Institute
Department

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
URL(English) https://upload.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


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