Unique ID issued by UMIN | UMIN000041400 |
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Receipt number | R000047265 |
Scientific Title | The effect of position therapy device on sleep parameters in patients with positional obstructive sleep apnea. |
Date of disclosure of the study information | 2020/08/13 |
Last modified on | 2022/02/12 10:39:09 |
The effect of position therapy device on sleep parameters in patients with positional obstructive sleep apnea.
The effect of PTD on sleep parameters in patients with POSA.
The effect of position therapy device on sleep parameters in patients with positional obstructive sleep apnea.
The effect of PTD on sleep parameters in patients with POSA.
Japan |
obstructive sleep apnea
Oto-rhino-laryngology |
Others
NO
to investigate the effect of the postion therapy device on sleep parameters in patients with obstructive sleep apnea.
Efficacy
AHI(/h)
%supine(%)
%snoring time(%)
arousal index(/h)
respiratory arousal index(/h)
spontaneous arousal index(/h)
sleep efficiency(%)
%wake (%)
%REM(%)
%N1 (%)
%N2 (%)
%N3 (%)
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Device,equipment |
position therapy device-set polysomnography(n=80)
oral appliance-set polysomnography (n=80)
22 | years-old | <= |
70 | years-old | >= |
Male and Female
the apnea hypopnea index score was 5 per hour or more by the PSG.
five or more central sleep apnea events per hour at a baseline PSG, patient not willing to cooperate ,prefer early continuous positive airway pressure or surgical treatments, evidence of tonsil hypertrophy, nasal obstruction or any diseases in the nasal cavity, uncontrolled or serious illness i.e. chronic heart failure, pulmonary disease such as asthma or chronic obstructive pulmonary disease, any other comorbid sleep disorder that would compromise functional sleep assessment ,for example, narcolepsy, parasomnia, periodic limb movement disorder, or physical problems causing inability to sleep on the side
160
1st name | Masaaki |
Middle name | |
Last name | Suzuki |
Teikyo University Chiba Medical Center
Dept. of Otorhinolaryngology
299-0111
3426-3, Anesaki, Ichihara, Chiba, JAPAN
0436-62-1211
suzukima@med.teikyo-u.ac.jp
1st name | Masaaki |
Middle name | |
Last name | Suzuki |
Teikyo University Chiba Medical Center
Dept. of Otorhinolaryngology
299-0111
3426-3, Anesaki, Ichihara, Chiba, JAPAN
0436-62-1211
suzukima@med.teikyo-u.ac.jp
Teikyo University
Teikyo University
Self funding
Teikyo University IRB
2-11-1, Kaga, Itabashi-ku, Tokyo, JAPAN
03-3964-7256
turb-office@teikyo-u.ac.jp
NO
2020 | Year | 08 | Month | 13 | Day |
https://link.springer.com/article/10.1007/s00405-021-06817-2
Unpublished
https://link.springer.com/article/10.1007/s00405-021-06817-2
160
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
2022 | Year | 02 | Month | 12 | Day |
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
None
he PTD decreased the AHI from a mean of 24.2 to 16.7/h, and the OA decreased the AHI from 20.8 to 10.3/h. Percentage of snoring time decreased from 31.1 to 16.9 % in the PTD group, and from 41.2 to 30.7% in the OA group. There were no significant decreases between the two groups. The PTD decreased sleep-time percentage in the supine position from a mean of 67.4 to 4.5%, despite 5 patients who were unable to avoid the supine position. There were no significant differences in improvement in percentage of sleep efficiency, stage wake, stage N1, N2 and stage REM, overall arousal and respiratory arousal indices between the two groups. However, the spontaneous arousal index worsened in the OA responders but remained unchanged in the PTD responders. Percentage of stage N3 sleep (%N3) was improved in the PTD responders but not in the OA responders. There were significant differences in spontaneous arousal index and %N3 between the two groups.
Open public recruiting
2019 | Year | 09 | Month | 01 | Day |
2019 | Year | 09 | Month | 25 | Day |
2019 | Year | 09 | Month | 25 | Day |
2020 | Year | 12 | Month | 31 | Day |
2020 | Year | 08 | Month | 12 | Day |
2022 | Year | 02 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047265
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