Singing Exercises to Improve Symptoms of Snoring and Slee... | NCT01322334

Studies
Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea

NCT01322334

Sponsor

Royal Devon and Exeter NHS Foundation Trust

Status

Completed

Last Update Posted

Mar 24, 2011Estimated

Enrollment

127Actual

Phase

Not Applicable

Conditions

Snoring
Upper Airway Resistance Syndrome
Obstructive Sleep Apnea

Interventions

Singing exercises

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Nov 2007Actual

First Submitted Date

Mar 23, 2011

First Submission Date that Met QC Criteria

Mar 23, 2011

First Posted Date

Mar 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2011

Last Update Posted Date

Mar 24, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

127Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Singing exercises	Experimental		Behavioral: Singing exercises

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Singing exercises	Behavioral	A 3 month self-guided treatment based on a specially designed 3CD box set, which patient performed every day ('Singing for Snorers': UK)	Singing exercises

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Epworth sleepiness scale		Entry to study (day one), and after 3 months of intervention

Secondary Outcomes

Measure	Description	Time Frame
Loudness of snoring	Visual analogue scale rating	Entry to study (day one), and 3 months after intervention
Frequency of snoring	Visual analogue scale rating

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Malcolm P Hilton, BMBCh FRCS	Royal Devon and Exeter NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Devon & Exeter NHS Foundation Trust		Exeter		EX2 5DW	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D012913	Snoring
D020181	Sleep Apnea, Obstructive
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D012135	Respiratory Sounds
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided