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Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea

This study has been completed.
Sponsor:
Information provided by:
Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01322334
First received: March 23, 2011
Last updated: NA
Last verified: March 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Snoring
Upper Airway Resistance Syndrome
Obstructive Sleep Apnea
 Behavioral: Singing exercises

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Single Blinded Prospective Randomized Controlled Trial to Investigate Whether Singing Exercises Can Improve Symptoms of Snoring and Sleep Apnea

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Royal Devon and Exeter NHS Foundation Trust:

Primary Outcome Measures:
  • Epworth sleepiness scale [ Time Frame: Entry to study (day one), and after 3 months of intervention ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Loudness of snoring [ Time Frame: Entry to study (day one), and 3 months after intervention ] [ Designated as safety issue: No ]
    Visual analogue scale rating

  • Frequency of snoring [ Time Frame: Entry to study (day one), and 3 months after intervention ] [ Designated as safety issue: No ]
    Visual analogue scale rating

  • SF-36 quality of life assessment tool [ Time Frame: Entry to study (day one), and 3 months after intervention ] [ Designated as safety issue: No ]
  • Compliance with exercises [ Time Frame: After 3 months of intervention ] [ Designated as safety issue: No ]
    Applied only to intervention group. Rated on visual analogue scale of 100mm from 'never' to 'every day'


Enrollment: 127
Study Start Date: November 2005
Study Completion Date: November 2007
Arms Assigned Interventions
Experimental: Singing exercises 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322334

Locations
United Kingdom
Royal Devon & Exeter NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Investigators
Principal Investigator: Malcolm P Hilton, BMBCh FRCS Royal Devon & Exeter NHS foundation trust
  More Information

No publications provided

Responsible Party: Malcolm Hilton, Consultant Otolaryngologist and Clinical Lecturer, Royal Devon & Exeter hospital
ClinicalTrials.gov Identifier: NCT01322334     History of Changes
Other Study ID Numbers: Hil2003/SE
Study First Received: March 23, 2011
Last Updated: March 23, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Devon and Exeter NHS Foundation Trust:
Snoring
Sleep apnea
Pharyngeal muscle tone

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Snoring
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Respiratory Sounds

ClinicalTrials.gov processed this record on May 16, 2013