NCT01322334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

First QC Date

March 23, 2011

Last Update Submit

March 23, 2011

Conditions

SnoringUpper Airway Resistance SyndromeObstructive Sleep Apnea

Keywords

SnoringSleep apneaPharyngeal muscle tone

Outcome Measures

Primary Outcomes (1)

  • Epworth sleepiness scale

    Entry to study (day one), and after 3 months of intervention

Secondary Outcomes (4)

  • Loudness of snoring

    Entry to study (day one), and 3 months after intervention

  • Frequency of snoring

    Entry to study (day one), and 3 months after intervention

  • SF-36 quality of life assessment tool

    Entry to study (day one), and 3 months after intervention

  • Compliance with exercises

    After 3 months of intervention

Study Arms (1)

Singing exercises

EXPERIMENTAL
Behavioral: Singing exercises

Interventions

Singing exercisesBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 years old or over
  • history of simple snoring or sleep apnoea with RDI 10-40

You may not qualify if:

  • severe sleep apnoea RDI \>40
  • morbid obesity BMI \> 40
  • unable to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Devon & Exeter NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

SnoringSleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Respiratory SoundsSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Malcolm P Hilton, BMBCh FRCS

    Royal Devon and Exeter NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 23, 2011

First Posted

March 24, 2011

Study Start

November 1, 2005

Study Completion

November 1, 2007

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations

GB(1)