UMIN-CTR Clinical Trial

Basic information
Public title	The effect of position therapy device on sleep parameters in patients with positional obstructive sleep apnea.
Acronym	The effect of PTD on sleep parameters in patients with POSA.
Scientific Title	The effect of position therapy device on sleep parameters in patients with positional obstructive sleep apnea.
Scientific Title:Acronym	The effect of PTD on sleep parameters in patients with POSA.
Region	Japan

Condition
Condition	obstructive sleep apnea
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate the effect of the postion therapy device on sleep parameters in patients with obstructive sleep apnea.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	AHI(/h) %supine(%) %snoring time(%) arousal index(/h) respiratory arousal index(/h) spontaneous arousal index(/h) sleep efficiency(%) %wake (%) %REM(%) %N1 (%) %N2 (%) %N3 (%)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	position therapy device-set polysomnography(n=80)
Interventions/Control_2	oral appliance-set polysomnography (n=80)
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	22 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	the apnea hypopnea index score was 5 per hour or more by the PSG.
Key exclusion criteria	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
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Masaaki Middle name Last name Suzuki
Organization	Teikyo University Chiba Medical Center
Division name	Dept. of Otorhinolaryngology
Zip code	299-0111
Address	3426-3, Anesaki, Ichihara, Chiba, JAPAN
TEL	0436-62-1211
Email	suzukima@med.teikyo-u.ac.jp

Public contact
Name of contact person	1st name Masaaki Middle name Last name Suzuki
Organization	Teikyo University Chiba Medical Center
Division name	Dept. of Otorhinolaryngology
Zip code	299-0111
Address	3426-3, Anesaki, Ichihara, Chiba, JAPAN
TEL	0436-62-1211
Homepage URL
Email	suzukima@med.teikyo-u.ac.jp

Sponsor
Institute	Teikyo University
Institute
Department

Funding Source
Organization	Teikyo University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Teikyo University IRB
Address	2-11-1, Kaga, Itabashi-ku, Tokyo, JAPAN
Tel	03-3964-7256
Email	turb-office@teikyo-u.ac.jp

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	2020 Year 08 Month 13 Day

Related information
URL releasing protocol	https://link.springer.com/article/10.1007/s00405-021-06817-2
Publication of results	Unpublished

Result
URL related to results and publications	https://link.springer.com/article/10.1007/s00405-021-06817-2
Number of participants that the trial has enrolled	160
Results	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.
Results date posted	2022 Year 02 Month 12 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	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.
Participant flow	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.
Adverse events	None
Outcome measures	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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2019 Year 09 Month 01 Day
Date of IRB	2019 Year 09 Month 25 Day
Anticipated trial start date	2019 Year 09 Month 25 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 12 Day
Last modified on	2022 Year 02 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047265