UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055193 |
|---|---|
| Receipt number | R000062972 |
| Scientific Title | Exploratory research to Establish the Strategy for Personalized Therapy with CPAP: Association between Patient Profile and Pressure Change Algorithm of Auto-CPAP |
| Date of disclosure of the study information | 2024/08/07 |
| Last modified on | 2025/08/08 16:58:29 |
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Basic information
Public title
Exploratory research to Establish the Strategy for Personalized Therapy with CPAP: Association between Patient Profile and Pressure Change Algorithm of Auto-CPAP
Acronym
Exploratory research for Personalized Therapy with CPAP
Scientific Title
Exploratory research to Establish the Strategy for Personalized Therapy with CPAP: Association between Patient Profile and Pressure Change Algorithm of Auto-CPAP
Scientific Title:Acronym
Exploratory research for Personalized Therapy with CPAP
Region
| Japan |
Condition
Condition
Obstructive Sleep Apnea
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although continuous positive airway pressure therapy (CPAP) has been established as standard therapy for obstructive sleep apnea (OSA), CPAP adherence has been reported to be unsatisfactory. We consider that one of the factors affecting CPAP adherence would be differences in pressure change algorithms between CPAP manufacturing companies. However, none has done the study focused on this issue. Assumably, prescribing appropriate CPAP to the patient according to the patient's preference improves CPAP adherence. Thus, in the current study, we evaluate the associations between patient preference for the pressure change algorithm and treatment efficacy and patient profile to prove the importance of individuality in choosing CPAP devices utilizing a new CPAP device which equips three automatic pressure change algorithms. Then our goal would be personalized therapy with CPAP for patients with OSA.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Patients preference for three automatic pressure change algorithms
2. Identified Cluster reflecting the patient profile. Clustering is performed using the patient characteristics, symptoms, and polysomnographic parameters.
The association between the above two factors will be evaluated.
Key secondary outcomes
1. CPAP adherence and treatment efficacy with each pressure change algorithm. Data is obtained from a CPAP memory card.
2. As for the patients who changed new CPAP from the one they used before they enrolled in this study, the association between patient preference for the pressure change algorithm and previously used CPAP device will be investigated.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The patient uses each mode among three automatic pressure change algorithms for every two weeks, which are soft, normal, and hard modes.
We adopted two orders as follows:
Pattern A. Soft -> Normal -> Hard
Pattern B. Hard -> Normal -> Soft
The order will be randomly assigned and blinded to the patient.
Interventions/Control_2
The patient uses each mode among three automatic pressure change algorithms for every two weeks, which are soft, normal, and hard modes.
We adopted two orders as follows:
Pattern A. Soft -> Normal -> Hard
Pattern B. Hard -> Normal -> Soft
The order will be randomly assigned and blinded to the patient.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who are newly diagnosed with OSA and satisfy the eligibility for CPAP therapy.
2. Among patients who are already treated with CPAP, patients who present poor CPAP adherence or are not happy with the CPAP device.
Key exclusion criteria
1. Patients with cardiovascular diseases such as stroke, heart failure, ischemic heart disease, and arrhythmia including atrial fibrillation which may cause central sleep apnea with Cheyne-Stokes breathing.
2. Patients with severe COPD and neuromuscular diseases which might cause sleep-related hypoventilation.
3. Patients with uncontrollable other sleep-related disorders including insomnia, hypersomnia, parasomnia, and sleep-related movement disorder.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Motoo |
| Middle name | |
| Last name | Yamauchi |
Organization
Nara Medical University
Division name
Department of Clinical Pathophysiology of Nursing / Department of Respiratory Medicine
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL
0744-22-3051
motoo@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Motoo |
| Middle name | |
| Last name | Yamauchi |
Organization
Nara Medical University
Division name
Department of Clinical Pathophysiology of Nursing / Department of Respiratory Medicine
Zip code
634-8522
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL
0744-22-3051
Homepage URL
motoo@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Murata Manufacturing Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Committee of Nara Medical University
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
Tel
0744-22-3051
ino_rinri@naramed-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
岩手医科大学附属病院（岩手県）、霧ヶ丘つだ病院（福岡県）、くわみず病院（熊本県）、かごしま高岡病院（鹿児島県）、RESM新横浜睡眠・呼吸メディカルケアクリニック（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062972
