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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01322334
Other study ID # Hil2003/SE
Secondary ID
Status Completed
Phase N/A
First received March 23, 2011
Last updated March 23, 2011
Start date November 2005
Est. completion date November 2007

Study information

Verified date March 2011
Source Royal Devon and Exeter NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Intervention

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)

Locations

Country Name City State
United Kingdom Royal Devon & Exeter NHS Foundation Trust Exeter

Sponsors (1)

Lead Sponsor Collaborator
Royal Devon and Exeter NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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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