Obstructive Sleep Apnea Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 127 |
Est. completion date | November 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Devon & Exeter NHS Foundation Trust | Exeter |
Lead Sponsor | Collaborator |
---|---|
Royal Devon and Exeter NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Epworth sleepiness scale | Entry to study (day one), and after 3 months of intervention | No | |
Secondary | Loudness of snoring | Visual analogue scale rating | Entry to study (day one), and 3 months after intervention | No |
Secondary | Frequency of snoring | Visual analogue scale rating | Entry to study (day one), and 3 months after intervention | No |
Secondary | SF-36 quality of life assessment tool | Entry to study (day one), and 3 months after intervention | No | |
Secondary | Compliance with exercises | Applied only to intervention group. Rated on visual analogue scale of 100mm from 'never' to 'every day' | After 3 months of intervention | No |
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