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Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01322334
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : March 24, 2011
Sponsor:
Information provided by:
Royal Devon and Exeter NHS Foundation Trust

Tracking Information
First Submitted Date  ICMJE March 23, 2011
First Posted Date  ICMJE March 24, 2011
Last Update Posted Date March 24, 2011
Study Start Date  ICMJE November 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2011)		 Epworth sleepiness scale [ Time Frame: Entry to study (day one), and after 3 months of intervention ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2011)
  • Loudness of snoring [ Time Frame: Entry to study (day one), and 3 months after intervention ]
    Visual analogue scale rating
  • Frequency of snoring [ Time Frame: Entry to study (day one), and 3 months after intervention ]
    Visual analogue scale rating
  • SF-36 quality of life assessment tool [ Time Frame: Entry to study (day one), and 3 months after intervention ]
  • Compliance with exercises [ Time Frame: After 3 months of intervention ]
    Applied only to intervention group. Rated on visual analogue scale of 100mm from 'never' to 'every day'
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea
Official Title  ICMJE A Single Blinded Prospective Randomized Controlled Trial to Investigate Whether Singing Exercises Can Improve Symptoms of Snoring and Sleep Apnea
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Snoring
  • Upper Airway Resistance Syndrome
  • Obstructive Sleep Apnea
Intervention  ICMJE Behavioral: Singing exercises
A 3 month self-guided treatment based on a specially designed 3CD box set, which patient performed every day ('Singing for Snorers': UK)
Study Arms  ICMJE Experimental: Singing exercises
Intervention: Behavioral: Singing exercises
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2011)		 127
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01322334
Other Study ID Numbers  ICMJE Hil2003/SE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Malcolm Hilton, Consultant Otolaryngologist and Clinical Lecturer, Royal Devon & Exeter hospital
Study Sponsor  ICMJE Royal Devon and Exeter NHS Foundation Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Malcolm P Hilton, BMBCh FRCS Royal Devon and Exeter NHS Foundation Trust
PRS Account Royal Devon and Exeter NHS Foundation Trust
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP