Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea
Primary Purpose
Snoring, Upper Airway Resistance Syndrome, Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Singing exercises
Sponsored by
About this trial
This is an interventional treatment trial for Snoring focused on measuring Snoring, Sleep apnea, Pharyngeal muscle tone
Eligibility Criteria
Inclusion Criteria:
- age 18 years old or over
- history of simple snoring or sleep apnoea with RDI 10-40
Exclusion Criteria:
- severe sleep apnoea RDI >40
- morbid obesity BMI > 40
- unable to provide written informed consent
Sites / Locations
- Royal Devon & Exeter NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Singing exercises
Arm Description
Outcomes
Primary Outcome Measures
Epworth sleepiness scale
Secondary Outcome Measures
Loudness of snoring
Visual analogue scale rating
Frequency of snoring
Visual analogue scale rating
SF-36 quality of life assessment tool
Compliance with exercises
Applied only to intervention group. Rated on visual analogue scale of 100mm from 'never' to 'every day'
Full Information
NCT ID
NCT01322334
First Posted
March 23, 2011
Last Updated
March 23, 2011
Sponsor
Royal Devon and Exeter NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01322334
Brief Title
Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea
Official Title
A Single Blinded Prospective Randomized Controlled Trial to Investigate Whether Singing Exercises Can Improve Symptoms of Snoring and Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Devon and Exeter NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Upper airway resistance during sleep can present with a range of symptoms from simple snoring (SS) through to severe obstructive sleep apnea (OSA). Pharyngeal narrowing or collapse leads to reduction or cessation in airflow during sleep, and is associated with loud snoring.
The investigators hypothesized that regular singing exercises could strengthen pharyngeal muscles and/or increase their resting tone, and lead to an improvement of symptoms and thus quality of life in patients with all forms of snoring.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Upper Airway Resistance Syndrome, Obstructive Sleep Apnea
Keywords
Snoring, Sleep apnea, Pharyngeal muscle tone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
127 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Singing exercises
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Singing exercises
Intervention Description
A 3 month self-guided treatment based on a specially designed 3CD box set, which patient performed every day ('Singing for Snorers': UK)
Primary Outcome Measure Information:
Title
Epworth sleepiness scale
Time Frame
Entry to study (day one), and after 3 months of intervention
Secondary Outcome Measure Information:
Title
Loudness of snoring
Description
Visual analogue scale rating
Time Frame
Entry to study (day one), and 3 months after intervention
Title
Frequency of snoring
Description
Visual analogue scale rating
Time Frame
Entry to study (day one), and 3 months after intervention
Title
SF-36 quality of life assessment tool
Time Frame
Entry to study (day one), and 3 months after intervention
Title
Compliance with exercises
Description
Applied only to intervention group. Rated on visual analogue scale of 100mm from 'never' to 'every day'
Time Frame
After 3 months of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18 years old or over
history of simple snoring or sleep apnoea with RDI 10-40
Exclusion Criteria:
severe sleep apnoea RDI >40
morbid obesity BMI > 40
unable to provide written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malcolm P Hilton, BMBCh FRCS
Organizational Affiliation
Royal Devon and Exeter NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Devon & Exeter NHS Foundation Trust
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
12. IPD Sharing Statement
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Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea
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