- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01322334
Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea
A Single Blinded Prospective Randomized Controlled Trial to Investigate Whether Singing Exercises Can Improve Symptoms of Snoring and Sleep Apnea
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Exeter, United Kingdom, EX2 5DW
- Royal Devon & Exeter NHS Foundation Trust
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Epworth sleepiness scale
Time Frame: Entry to study (day one), and after 3 months of intervention
|
Entry to study (day one), and after 3 months of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loudness of snoring
Time Frame: Entry to study (day one), and 3 months after intervention
|
Visual analogue scale rating
|
Entry to study (day one), and 3 months after intervention
|
|
Frequency of snoring
Time Frame: Entry to study (day one), and 3 months after intervention
|
Visual analogue scale rating
|
Entry to study (day one), and 3 months after intervention
|
|
SF-36 quality of life assessment tool
Time Frame: Entry to study (day one), and 3 months after intervention
|
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'
|
After 3 months of intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Malcolm P Hilton, BMBCh FRCS, Royal Devon and Exeter NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hil2003/SE
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