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
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
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
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
