SnoringNCT01223859
Pretreatment Assessment of Oropharynx Ans Soft Palate Radiofrequency Surgery - a Multi-center Study
A study testing Interstitial soft palate surgery in people with Snoring, run by University of Helsinki.
Trial summary
Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in the treatment of habitual snoring. The decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Snoring
- What is being tested?
- Interstitial soft palate surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2010
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
TABLE 1. The inclusion and exclusion criterion used for the multicenter study.
Criteria Inclusion Exclusion _____________
Age (years) 18-65 < 18, > 65
Habitual snoring yes no Excessive daytime sleepiness no yes
BMI (kg/m2) < 28 > 28
AHI (events/hour) < 15 > 15
Overjet (mm) < 5 > 5 Clinical suspicion of obstruction no yes at base of tongue
Size of palatine tonsils (grade) 0-II III-IV
Nose breathing problems no yes
Pharyngeal tonsil hypertrophy no yes
A bed partner to assess snoring yes no
_____________
Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.
About this study
Official title: The Impact of Pretreatment Assessment of Oropharynx on Interstitial Soft Palate Radiofrequency Surgery Outcome - a Multi-center Study in Patients With Habitual Snoring
Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in the treatment of habitual snoring. The decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to investigate the correlation of systematic clinical pretreatment oropharyngeal examination scores with the efficacy of interstitial RF surgery of SP in a multi-center study
Read the detailed description
TABLE 1. The inclusion and exclusion criterion used for the multicenter study.
Criteria Inclusion Exclusion _____________
Age (years) 18-65 < 18, > 65
Habitual snoring yes no Excessive daytime sleepiness no yes
BMI (kg/m2) < 28 > 28
AHI (events/hour) < 15 > 15
Overjet (mm) < 5 > 5 Clinical suspicion of obstruction no yes at base of tongue
Size of palatine tonsils (grade) 0-II III-IV
Nose breathing problems no yes
Pharyngeal tonsil hypertrophy no yes
A bed partner to assess snoring yes no
_____________
Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.
- Conditions
- Snoring
- Being tested
- Interstitial soft palate surgery
- Keywords
- Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstitial soft palate surgeryProcedure or surgery
Also called RFA, RFTA
Soft palate RF surgery in local anaesthesia
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Interstitial soft palate RF surgery Receives: Procedure: Interstitial soft palate surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual analogue scale snoring patient and bed partner
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2010 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany, Helsinki University Central Hospital
- Investigators
- Leif JJ Bäck, MD PhD, Study director, Helsinki University Dept of ORL HN Surg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01223859
- Sponsor's protocol ID
- lefa
- Status last verified
- Oct 2007
- First submitted
- 18 Oct 2010
- Last updated
- 19 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Back LJ, Koivunen P, Pyykko I, Stene BK, Makitie AA. The impact of pretreatment assessment of oropharynx on interstitial soft palate radiofrequency surgery outcome--a multi-center study in patients with habitual snoring. Sleep Breath. 2012 Mar;16(1):199-204. doi: 10.1007/s11325-011-0490-4. Epub 2011 Feb 12.
PubMed 21311985
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Pretreatment Assessment of Oropharynx on Interstitial Soft Palate Radiofrequency Surgery Outcome - a Multi-center Study in Patients With Habitual Snoring
- ClinicalTrials.gov ID
- NCT01223859
- Acronym / sponsor ID
- lefa
- Conditions
- Snoring
- Keywords
- Radiofrequency, ablation, RFA, RFTA, RFITT, soft palate.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Olympus Surgical Technologies Europe, Celon Ag Medical Instruments, Teltow, Germany, Helsinki University Central Hospital
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 19 Oct 2010 (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.
Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in the treatment of habitual snoring. The decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to investigate the correlation of systematic clinical pretreatment oropharyngeal examination scores with the efficacy of interstitial RF surgery of SP in a multi-center study
Detailed description
TABLE 1. The inclusion and exclusion criterion used for the multicenter study.
Criteria Inclusion Exclusion _____________
Age (years) 18-65 < 18, > 65
Habitual snoring yes no Excessive daytime sleepiness no yes
BMI (kg/m2) < 28 > 28
AHI (events/hour) < 15 > 15
Overjet (mm) < 5 > 5 Clinical suspicion of obstruction no yes at base of tongue
Size of palatine tonsils (grade) 0-II III-IV
Nose breathing problems no yes
Pharyngeal tonsil hypertrophy no yes
A bed partner to assess snoring yes no
_____________
Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: Interstitial soft palate surgeryInterstitial soft palate RF surgery |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Interstitial soft palate surgeryAlso: RFA, RFTASoft palate RF surgery in local anaesthesia | Procedure or surgery | intervention |
Primary outcome
VAS
Time frame: 3 months postoperatively
Visual analogue scale snoring patient and bed partner
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 19 Oct 2010.
- Derived from this study: PubMed 21311985Back LJ, Koivunen P, Pyykko I, Stene BK, Makitie AA. The impact of pretreatment assessment of oropharynx on interstitial soft palate radiofrequency surgery outcome--a multi-center study in patients with habitual snoring. Sleep Breath. 2012 Mar;16(1):199-204. doi: 10.1007/s11325-011-0490-4. Epub 2011 Feb 12.
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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.
Leif JJ Bäck, MD PhD study director
Helsinki University Dept of ORL HN Surg
Questions about this trial
What is this clinical trial studying?
A study testing Interstitial soft palate surgery in people with Snoring, run by University of Helsinki.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
VAS (time frame: 3 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01223859, which also lists 1 linked publication.
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 19 Oct 2010.