UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061257 |
|---|---|
| Receipt number | R000069331 |
| Scientific Title | Impact of open Septorhinoplasty on Obstructive Sleep Apnea and Nasal Symptoms: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/04/14 |
| Last modified on | 2026/04/14 14:58:56 |
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Basic information
Public title
Impact of Septorhinoplasty on Obstructive Sleep Apnea and Nasal Symptoms: A Prospective Observational Study
Acronym
OSRP-OSA Study
Scientific Title
Impact of open Septorhinoplasty on Obstructive Sleep Apnea and Nasal Symptoms: A Prospective Observational Study
Scientific Title:Acronym
OSRP-OSA
Region
| Japan |
Condition
Condition
Nasal obstruction; Obstructive sleep apnea; Deviated nasal septum
Classification by specialty
| Cardiology | Psychiatry | Oto-rhino-laryngology |
| Oral surgery | Plastic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate, from both subjective and objective perspectives, the extent to which improvement in nasal airflow following OSRP contributes to changes in the severity of OSA and patient-reported nocturnal nasal obstruction symptoms. In addition, this study will exploratorily assess the potential for resumption of treatment in patients in whom nasal obstruction had interfered with the initiation or continuation of continuous positive airway pressure (CPAP) therapy. Furthermore, it aims to investigate the prevalence of undiagnosed OSA among patients undergoing OSRP primarily for nasal obstruction.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the respiratory event index (REI) from preoperative baseline to 6 months postoperatively
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Open septorhinoplasty will be performed, and daytime sleepiness questionnaires and portable sleep apnea monitor assessments will be conducted before and after surgery.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing open septorhinoplasty (OSRP) at the Department of Plastic and Reconstructive Surgery, The Jikei University Hospital; age over 18 years; patients able to undergo both preoperative and postoperative assessments, including the Japanese version of the Standardized Cosmesis and Health Nasal Outcomes Survey (J-SCHNOS), the Japanese version of the Epworth Sleepiness Scale (JESS), and portable sleep apnea testing; patients who provide written informed consent to participate in this study
Key exclusion criteria
Patients deemed unlikely to complete follow-up through 12 months postoperatively; patients for whom study assessments are considered inappropriate due to severe comorbidities or acute illnesses; pregnant patients or those who may be pregnant; patients who are not native Japanese speakers; patients with a history of craniofacial trauma within the past 3 months
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Ato |
| Middle name | |
| Last name | Hamasaki |
Organization
The Jikei University Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
105-8471
Address
3-19-18 Nishi-Shimbashi, Minato-ku, Tokyo 105-8471, Japan
TEL
03-3433-1111
atohamasaki@gmail.com
Public contact
Name of contact person
| 1st name | Ato |
| Middle name | |
| Last name | Hamasaki |
Organization
The Jikei University Hospital
Division name
Department of Plastic and Reconstructive Surgery
Zip code
105-8471
Address
3-19-18 Nishi-Shimbashi, Minato-ku, Tokyo 105-8471, Japan
TEL
03-3433-1111
Homepage URL
atohamasaki@gmail.com
Sponsor or person
Institute
The Jikei University
Institute
Department
Personal name
Funding Source
Organization
Teijin Pharma Limited
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
Ethics Committee of The Jikei University School of Medicine
Address
3-19-18 Nishi-Shimbashi, Minato-ku, Tokyo 105-8471, Japan
Tel
03-3433-1111
rinri@jikei.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
| 2026 | Year | 04 | Month | 14 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2029 | 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
| 2026 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069331
