SnoringNCT01322334
Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea
A study testing Singing exercises in people with Snoring and Upper Airway Resistance Syndrome, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Snoring, Upper Airway Resistance Syndrome, Obstructive Sleep Apnea
- What is being tested?
- Singing exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2005to Nov 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years old or over
- history of simple snoring or sleep apnoea with RDI 10-40
Who cannot join
- severe sleep apnoea RDI >40
- morbid obesity BMI > 40
- unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon & Exeter NHS Foundation Trust
Exeter, EX2 5DW
About this study
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.
- Being tested
- Singing exercises
- Keywords
- Snoring, Sleep apnea, Pharyngeal muscle tone
- Medical subject headings
- Snoring, Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Singing exercisesBehavioural
A 3 month self-guided treatment based on a specially designed 3CD box set, which patient performed every day ('Singing for Snorers': UK)
| Study group | Role | What they receive |
|---|---|---|
| Singing exercises | Experimental | Not described Receives: Behavioral: Singing exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth sleepiness scale
Measured: Entry to study (day one), and after 3 months of intervention
Secondary outcomes (4)
Loudness of snoring
Visual analogue scale rating
Measured: Entry to study (day one), and 3 months after intervention
Frequency of snoring
Visual analogue scale rating
Measured: Entry to study (day one), and 3 months after intervention
SF-36 quality of life assessment tool
Measured: Entry to study (day one), and 3 months after intervention
Compliance with exercises
Applied only to intervention group. Rated on visual analogue scale of 100mm from 'never' to 'every day'
Measured: After 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startNov 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- Malcolm P Hilton, BMBCh FRCS, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322334
- Sponsor's protocol ID
- Hil2003/SE
- Status last verified
- Mar 2011
- First submitted
- 23 Mar 2011
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Blinded Prospective Randomized Controlled Trial to Investigate Whether Singing Exercises Can Improve Symptoms of Snoring and Sleep Apnea
- ClinicalTrials.gov ID
- NCT01322334
- Acronym / sponsor ID
- Hil2003/SE
- Keywords
- Snoring, Sleep apnea, Pharyngeal muscle tone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Singing exercises | Experimental | Behavioral: Singing exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 years old or over
- history of simple snoring or sleep apnoea with RDI 10-40
Key exclusion criteria (3 listed)
- severe sleep apnoea RDI >40
- morbid obesity BMI > 40
- unable to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Singing exercisesA 3 month self-guided treatment based on a specially designed 3CD box set, which patient performed every day ('Singing for Snorers': UK) | Behavioural | Singing exercises |
Primary outcome
Epworth sleepiness scale
Time frame: Entry to study (day one), and after 3 months of intervention
4 secondary outcomes
Loudness of snoring
Time frame: 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
SF-36 quality of life assessment tool
Time frame: Entry to study (day one), and 3 months after intervention
Compliance with exercises
Time frame: After 3 months of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malcolm P Hilton, BMBCh FRCS principal investigator
Royal Devon and Exeter NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Singing exercises in people with Snoring and Upper Airway Resistance Syndrome, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth sleepiness scale (time frame: Entry to study (day one), and after 3 months of intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2011.