UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of a novel hypoxic training method using carbon dioxide.
Title of the study (Brief title)	Development of a novel hypoxic training method using carbon dioxide.
Region	Japan

Condition
Condition	Healthy adults subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In competitive sports, high-altitude training enhances the effects of training but can be associated with a risk of overtraining, since recovery from fatigue through sleep is slower at high altitude than at sea level. High-altitude sleep is characterized by reduced sleep quality resulting from an increase in arousal during sleep and a decrease in the duration of slow-wave sleep due to central sleep apnea. The objectives of this study are to establish a novel hypoxic training method (hypoxic carbon dioxide loading) that involves artificially controlling end-tidal carbon dioxide partial pressure during sleep in a hypoxic environment to values experienced during normal sleep at sea level in order to reduce central apnea and to obtain physiological basic data that provide scientific evidence for the training method.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Apnea
Key secondary outcomes	Sleep structure, End-tidal carbon dioxide partial pressure:

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Other
Interventions/Control_1	After normal sleep conditions, hypoxic sleep conditions will be performed and subsequently hypoxic carbon dioxide load sleep conditions will be performed. Exposure time under sleep conditions will be 7 hours. Three conditions will be three days successively. Oxygen concentration of inspiration will be set at 15.4%, which corresponds to the concentration at 2500 m above sea level in hypoxic sleep conditions. During sleep hypoxic carbon dioxide load sleep conditions, oxygen concentration of inspiration will be set at 15.4% and the carbon dioxide concentration in the sleeping room will be adjusted 1500 ppm.
Interventions/Control_2	After normal sleep conditions, hypoxic carbon dioxide load sleep conditions will be performed and subsequently hypoxic sleep conditions will be performed. Exposure time under sleep conditions will be 7 hours. Three conditions will be three days successively. Oxygen concentration of inspiration will be set at 15.4%, which corresponds to the concentration at 2500 m above sea level in hypoxic sleep conditions. During sleep hypoxic carbon dioxide load sleep conditions, oxygen concentration of inspiration will be set at 15.4% and the carbon dioxide concentration in the sleeping room will be adjusted 1500 ppm.
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	Inclusion criteria are as follows: Be in good health. Be aged over 20 years at the time of giving consent to study participation. Be able to fully understand this study plan and give their own consent, and have signed and dated the informed consent form prior to starting the study. Have normal nocturnal sleep patterns. Be able to sleep at the university laboratory at night. Be able to comply with the specified sleep/arousal rhythm.
Key exclusion criteria	Outpatients judged by their physicians to be ineligible for participation in the study Anyone diagnosed with sleep disorder (International Classification of Sleep Disorders, Second Edition) Participation judged inappropriate by an investigator Unable to attend on any designated study days Unable to comply with the specified sleep/arousal rhythm
Target sample size	8

Research contact person
Name of lead principal investigator	Takeshi Yamauchi
Organization	Ishinomaki Senshu University
Division name	School of Human studies
Address	1 Shinmito Minamisakai Ishinomaki
TEL	0225-22-7711
Email	yamauchi@isenshu-u.ac.jp

Public contact
Name of contact person	Takeshi Yamauchi
Organization	Ishinomaki Senshu University
Division name	School of human studies
Address	1 Shinmito Minamisakai Ishinomaki
TEL	0225-22-7711
Homepage URL
Email	yamauchi@isenshu-u.ac.jp

Sponsor
Institute	Ishinomaki Senshu University
Institute
Department

Funding Source
Organization	Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization	Japanese Governmental office
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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 11 Month 10 Day
Last follow-up date	2017 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	A comparison of polysomnography (PSG), heart rate variability analysis, and oxygen desaturation indices (ODI) for low-oxygen trials (15.4% O2) and low-oxygen, high-carbon dioxide trials (15.4% O2, 1500 ppm CO2) was conducted. No statistical significance was found among Stages N1, N2, N3, and R. The heart rate variability analysis showed no statistical significance among RR interval (RRi), high frequency (HF), and the ratio of low frequency to high frequency (LF/HF). There was no statistical significance among blood oxygen saturation (SpO2), ODI3, and ODI4. The concentration of carbon dioxide (1500 ppm) in the room did not have an adverse effect on the physiological response while sleeping in a low-oxygen environment.
Other related information

Management information
Registered date	2015 Year 11 Month 04 Day
Last modified on	2018 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022517