UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The impact of obstructive sleep apnea on resting energy expenditure, sleep duration, and dietary habits: effects of continuous positive airway pressure
Title of the study (Brief title)	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	Kazuo Chin
Organization	Graduate school of medicine, Kyoto University
Division name	Resiratpry care and sleep control medicine
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	Ryo Tachikawa
Organization	Graduate school of medicine, Kyoto University
Division name	Respiratory medicine
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)

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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