UMIN-CTR Clinical Trial

Public title

The prevalence and occurrence of sleep apnea syndrome in head and neck tumor patients: the efficacy of pre- and posttreatment.

Acronym

Sleep apnea syndrome in head and neck tumor patients.

Scientific Title

The prevalence and occurrence of sleep apnea syndrome in head and neck tumor patients: the efficacy of pre- and posttreatment.

Scientific Title:Acronym

Sleep apnea syndrome in head and neck tumor patients.

Region

Japan

Condition

Head and neck tumor and sleep apnea syndrome.

Classification by specialty

Medicine in general

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the incidence of sleep apnea in head and neck tumor patients.
To evaluate the occurrence of sleep apnea after treatment of head and neck tumor.

Basic objectives2

Bio-equivalence

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Others

Developmental phase

Primary outcomes

This is prospective study for 12 months-follow-up.
Nasopharyngeal scope, blood tests, rhinometry and polysomnography are planned.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Continuous positive airway pressure therapy

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

Age-lower limit

30

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Head and neck tumor patients who receive infrmed consent.

Key exclusion criteria

Patients who die during the study period.

Target sample size

50

Name of lead principal investigator

1st name	Ayako
Middle name
Last name	Inoshita

Organization

Juntendo University School of Medicine, Juntendo Hospital

Division name

Otorhinolaryngology, Head and Neck Surgery

Zip code

1113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421

TEL

03-3813-3111

Email

ayaent@juntendo.ac.jp

Name of contact person

1st name	Ayako
Middle name
Last name	Inoshita

Organization

Juntendo University School of Medicine, Juntendo Hospital

Division name

Otorhinolaryngology, Head and Neck Surgery

Zip code

113-8431

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421

TEL

03-3813-3111

Homepage URL

Email

ayaent@juntendo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Organization

Teijin Pharma

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Juntendo Urayasu Hospital

Name of secondary funder(s)

Organization

Juntendo Clinical Research and Trial Cente

Address

3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8421

Tel

03-5802-1584

Email

kenkyu5858@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

04

Month

02

Day

URL releasing protocol

https://apm.amegroups.com/article/view/96851/html

Publication of results

Published

URL related to results and publications

https://apm.amegroups.com/article/view/96851/html

Number of participants that the trial has enrolled

32

Results

A total of 32 patients were underwent pre-treatment sleep tests. The prevalence of OSA was 81.3% before treatment. The mean AHI was 20.8 events/hr. Next, 21 patients were performed a sleep test both before and after treatment. Overall, the AHI was no significant difference, from 14.5 to 14.9 after treatment (P=0.147). The MRI parameters showed that the retroglossal pharyngeal area increased significantly after treatment (P=0.007).

Results date posted

2023

Year

04

Month

06

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

In recent years, a relatively high prevalence of obstructive sleep apnea (OSA) in patients following radiotherapy (RT) for head and neck cancer (HNC) has been reported; however, little is known regarding the impact of RT on sleep disorders and the underlying mechanisms. This aim of this study was to elucidate the pathogenesis of OSA by comparing the clinical and sleep test parameters and magnetic resonance imaging (MRI) findings before and after HNC treatment with radiation.

Participant flow

This prospective study included patients scheduled for RT with or without chemotherapy or bioradiotherapy for HNC. Patients diagnosed with HNC between May 2017 and August 2020 were consecutively recruited. The results of the sleep tests were analyzed both before and after treatment.

Adverse events

not specified.

Outcome measures

The clinical characteristics of the patients and cephalometric and MRI parameters were also measured.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2017

Year

04

Month

28

Day

Date of IRB

2017

Year

04

Month

28

Day

Anticipated trial start date

2017

Year

05

Month

01

Day

Last follow-up date

2021

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

04

Month

02

Day

Last modified on

2023

Year

04

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036584