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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	JPRN
Last refreshed on:	17 October 2023
Main ID:	JPRN-UMIN000024617
Date of registration:	04/11/2016
Prospective Registration:	Yes
Primary sponsor:	Division for Oral and Facial Disorders, Osaka University Dental Hospital
Public title:	The efficacy of nasal airway stent (nastentTM) in patient with obstructive sleep apnea
Scientific title:	The efficacy of nasal airway stent (nastentTM) in patient with obstructive sleep apnea - Nastent study
Date of first enrolment:	2016/11/30
Target sample size:	30
Recruitment status:	Complete: follow-up complete
URL:	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028321
Study type:	Interventional
Study design:	Single arm Non-randomized
Phase:	Not applicable

Countries of recruitment
Japan

Contacts

Name:	Takayoshi Sakai
Address:	1-8, Yamadaoka, Suita-city, Osaka, Japan, 565-0871 Japan
Telephone:	06-6879-2275
Email:	sakai@dent.osaka-u.ac.jp
Affiliation:	Osaka University Graduate School of Dentistry Division of Functional Oral Neuroscience

Name:	Kentaro Okuno
Address:	1-8, Yamadaoka, Suita-city, Osaka, Japan, 565-0871 Japan
Telephone:	06-6879-2278
Email:	k-okuno@dent.osaka-u.ac.jp
Affiliation:	Osaka University Dental Hospital Division for Oral and Facial Disorders

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: Patients who have a neuromuscular disease, severe heart disease and mental disease.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female

Health Condition(s) or Problem(s) studied

obstructive sleep apnea

Intervention(s)

Nastent treatment (1 month)

Primary Outcome(s)

The change of apnea hypopnea index (AHI) after one month treatment of nastent.

Secondary Outcome(s)

The change of minimum SpO2 after one month treatment of nastent.

Secondary ID(s)

Source(s) of Monetary Support

Division for Oral and Facial Disorders, Osaka University Dental Hospital

Secondary Sponsor(s)

seven dreamers laboratories, inc.

Ethics review

Status: YES
Approval date:
Contact:

Results

Results available:	Yes
Date Posted:
Date Completed:	31/03/2017
URL:

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