UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000019621
Receipt number	R000022517
Scientific Title	Development of a novel hypoxic training method using carbon dioxide.
Date of disclosure of the study information	2015/11/05
Last modified on	2018/11/16 10:03:17

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Basic information

Public title

Development of a novel hypoxic training method using carbon dioxide.

Acronym

Development of a novel hypoxic training method using carbon dioxide.

Scientific Title

Development of a novel hypoxic training method using carbon dioxide.

Scientific Title:Acronym

Development of a novel hypoxic training method using carbon dioxide.

Region

Japan

Condition

Healthy adults subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

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

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

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Takeshi Yamauchi

Organization

Ishinomaki Senshu University

Division name

School of Human studies

Zip code

Address

1 Shinmito Minamisakai Ishinomaki

TEL

0225-22-7711

Email

yamauchi@isenshu-u.ac.jp

Public contact

Name of contact person

1st name

Middle name

Last name Takeshi Yamauchi

Organization

Ishinomaki Senshu University

Division name

School of human studies

Zip code

Address

1 Shinmito Minamisakai Ishinomaki

TEL

0225-22-7711

Homepage URL

Email

yamauchi@isenshu-u.ac.jp

Sponsor or person

Institute

Ishinomaki Senshu University

Institute

Department

Personal name

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)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2015 Year 11 Month 05 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

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.

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

Completed

Date of protocol fixation

2015 Year 10 Month 01 Day

Date of IRB

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

Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022517