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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
Royal Devon and Exeter NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Snoring focused on measuring Snoring, Sleep apnea, Pharyngeal muscle tone

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
March 23, 2011
Last Updated
March 23, 2011
Sponsor
Royal Devon and Exeter NHS Foundation Trust
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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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