Unique ID issued by UMIN | UMIN000015581 |
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Receipt number | R000017128 |
Scientific Title | The study of sleep-disordered breathing at high altitude for evaluating and treatment |
Date of disclosure of the study information | 2014/11/01 |
Last modified on | 2015/05/01 09:14:54 |
The study of sleep-disordered breathing at high altitude for evaluating and treatment
SDBHA study
The study of sleep-disordered breathing at high altitude for evaluating and treatment
SDBHA study
Japan |
sleep-disordered breathing
Pneumology |
Others
NO
1. To evaluate the worsening and its risks of SDB under the hypoxic circumstances
2. To establish the treatment in SDB patients who will sleep at high altitude
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Apnea-hypopnea index(AHI)
Oxygen saturation (Time below 90% , or minimum)
Sleep quality
Complications
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine | Device,equipment |
To apply continuous positive airway pressure (CPAP) and acetazolamide p.o. for the eligible SDB patients
20 | years-old | <= |
Not applicable |
Male and Female
1. Subjects who will stay at high altitude
2. Suspected SDB patients who have 3% oxygen desaturation index (ODI3%) with over 5/h and less than 15/h
Unstable ishchemic heart disease
Pulmonary hypertension
History of strokes
Heart failure
Resiratory failure
Renal failure
Neuropsychologic disease
History of upper airway surgery
Treated with drugs affecting respiration and sleep( acetazolamide, benzodiazepines, narcotics
subjects who are judged unsuitable by doctors
20
1st name | |
Middle name | |
Last name | Yuichi Inoue |
Tokyo Medical University
Department of Sleep Medicine
6-1-1 Shinjuku, Shinjuku-ku, Tokyo
03-3351-6141
inoue@somnology.com
1st name | |
Middle name | |
Last name | Hideaki Nakayama |
Tokyo Medical University
Department of Respiratory Medicine
6-7-1 Nishi-shinjuku, Shinjuku-ku, Tokyo
03-3342-6111
hidenaka@tokyo-med.ac.jp
Department of Sleep Medicine
Tokyo Medical University
Department of Sleep Medicine
Tokyo Medical University
Self funding
NO
2014 | Year | 11 | Month | 01 | Day |
Unpublished
Terminated
2014 | Year | 07 | Month | 10 | Day |
2014 | Year | 11 | Month | 01 | Day |
Ceased due to no subject who would take part in the study.
2014 | Year | 11 | Month | 01 | Day |
2015 | Year | 05 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017128
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