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The Effect of Oropharyngeal – Lingual Exercises on Patients with Primary Snoring in Amiralmomenin's hospital refers.

Protocol summary

Summary
The prospective before - after study to investigate efficacy of oropharyngeal- lingual exercises (OPL exes) on primary snoring (PS) severity. From 20-65 years old patients who are referred to university Amiralmomenin Hospital, Rasht, because of primary snoring after clinical examinations including vital sign, ENT physical examinations, weight, height, neck and abdomen circumference, and history taking about daytime sleepiness, neuromuscular, thyroid, and cardiopulmonary diseases, and about snoring and its severity (from his/her roommate) we will receive a written informed consent for participating in the study. After that, a standard questionnaire about PS and its severity including Visual Analogue Scale (VAS) will be fulfilled by the patient and his/her roommate. Those patients suffering from severe pulmonary diseases; craniofacial malformations; those with regular use of hypnotic medications & severe obstructive nasal disease will not included in the study. Also, those with probability of severe obstructive sleep apnea syndrome (i.e. more than 5 apnea episodes, daytime sleepiness, Body Mass Index more than 30) will not included in the study. The eligible cases will be referred to voice therapy clinic and an expert voice therapist will train the cases OPL exercises in several sessions. These are a 3 set of exercises for soft palate (2 exercises), tongue (4 exercises), and buccal/facial muscles (5 exercises). After assurance from doing the exercises correctly, we will deliver a Compact Disc containing files of the films of the exercises to the patients and frequently call with them for checking the status of performing the exercises and frequent visits at 3-4 weeks intervals until 3 months. The exercises must be done at least 5 days in the week and 30 minutes daily. In every visit, quality of doing the exercises and severity of the exercises will be registered.Those who would not have the compliance of doing the exercises during last 3 months (according to the patients’ and their roommates confess or according to the speech therapist diagnosis with the accuracy of 80% in doing the exercises) and also those who will not fulfill the follow-up visits will be excluded from the study. The severity of the PS will be measured before and one week after the intervention according to the VAS and standard questionnaire.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201101101138N6
Registration date: 2011-05-24, 1390/03/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-05-24, 1390/03/03
Registrant information
Name
Fataneh Bakhshi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1223 8307
Email address
entrc@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences, Vice Chancellor for Research
Expected recruitment start date
2011-01-21, 1389/11/01
Expected recruitment end date
2011-10-23, 1390/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Oropharyngeal – Lingual Exercises on Patients with Primary Snoring in Amiralmomenin's hospital refers.
Public title
The Effect of Oropharyngeal – Lingual Exercises on Snoring
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: The patients who are 20-65 years old suffering from snoring Exclusion criteria : not suffering from primary snoring; patients suffering from severe pulmonary disease; craniofacial malformations; those with regular use of hypnotic medications; hypothyroidism; positive history of previous stroke; sinusitis; neuromuscular disease; heart failure; Coronary artery disease; severe obstructive nasal disease; Those who would not have the compliance of doing the exercises during last 3 months (according to the patients’ and their roommates confess or according to the speech therapist diagnosis with the accuracy of 80% in doing the exercises) and also those who will not fulfill the follow-up visits.
Age
From 20 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Guilan University of Medical Sciences
Street address
Siadati st.
City
Rasht
Postal code
Approval date
2010-12-11, 1389/09/20
Ethics committee reference number
11937

Health conditions studied

1

Description of health condition studied
snoring
ICD-10 code
R06.5
ICD-10 code description
Mouth breathing

Primary outcomes

1

Description
Primary Snoring Severity
Timepoint
before and one week after the intervention
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The eligible cases will be referred to voice therapy clinic and an expert voice therapist will train the cases oropharyngeal-lingual exercises in several sessions. These are a 3 set of exercises for soft palate (2 exercises), tongue (4 exercises), and buccal/facial muscles (5 exercises). After assurance from doing the exercises correctly, we will deliver a Compact Disc containing files of the films of the exercises to the patients and frequently call with them for checking the status of performing the exercises and frequent visits at 3-4 weeks intervals until 3 months. The exercises must be done at least 5 days in the week and 30 minutes daily. In every visit, quality of doing the exercises and severity of the exercises will be registered.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Dr Shadman Nemati
Street address
Amiralmomenin Hospital, 17 Shahrivar st.
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Susan Komaii
Street address
Namjou st. - Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences, Vice Chancellor for Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 Shahrivar st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Position
Assistant professor
Other areas of specialty/work
Street address
Amiralmomenin hospital, 17 Shahrivar st.
City
Rasht
Postal code
Phone
+98 13 1222 5242
Fax
Email
nemati@gums.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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