SnoringNCT02952118
Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study
A study testing Forrest Snoring device in people with Snoring, run by GE Sleeping.
Trial summary
This is an open, pilot study for adults ( age range of 20-70 years old), who suffer from snoring without obstructive sleep apnea (OSA) and no need for CPAP treatment: with standard diagnosis of sleep study or with minor sleep disorder (AHI of less than 15 events per hour). Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Snoring
- What is being tested?
- Forrest Snoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Nov 2017
- 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient age range : 20-70 years old.
- The patient / legal guardian able and willing to sign conscious written agreement.
- The patient / legal guardian able and willing to comply with the study protocol.
- The patient is suffering from snoring.
- The patient underwent a sleep study over the last year.
Who cannot join
- The patient suffers from sleep apnea that requires CPAP treatment: more than 15 AHI per hour in a sleep study or due to significant background diseases.
- Patient less than 20 years old.
About this study
This is an open, pilot study for adults ( age range of 20-70 years old), who suffer from snoring without obstructive sleep apnea (OSA) and no need for CPAP treatment: with standard diagnosis of sleep study or with minor sleep disorder (AHI of less than 15 events per hour). Patients with no OSA over the last year will sign an informed consent after receiving explanations from authorized physician (Professor Asher Tal). The patient will than undergo a sleep study using a mobile device PAT (Peripheral Arterial Tomography, Itamar Medical, Israel) ,an approved device in Israel, USA and many other European countries,, approved for use by the USA FDA). This sleep study is needed in order to rule out OSA, namely AHI of more than 15 events per hour of sleep.
The study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with PAT device, with snoring recording and without the "Forrest" epic device. In the second night the sleep study will be with PAT device, with snoring recording and with the "Forrest" epic device. The order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. The research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. The sleep studies will take place in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home.
Read more
Recordings over the nights with or without the "Forrest" epic device will be carried out at the patient's home, after verification that each patient sleeps alone in his/her room. The recording and data processing of snoring will be performed through the application "SNORLAB" on IPHONE 6 mobile device. Ambulatory sleep studies with PAT device will be carried out during two nights (with and without the Forrest Device) with most patients.
During the examination, respiratory index will be tested such as: obstructive respiratory events during sleep, oxygen saturation in blood at rest (measured non-invasively) during sleep: mean, lowest (nadir), and rate of time the patient sleeps in with less than 90% of oxygen saturation in blood.
- Conditions
- Snoring
- Being tested
- Forrest Snoring device
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forrest Snoring deviceDevice
| Study group | Role | What they receive |
|---|---|---|
| one night with the device and one night without the device. | Experimental | The study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with PAT device, with snoring recording and without the "Forrest" epic device. In the second night the sleep study will be with PAT device, with snoring recording and with the "Forrest" epic device. The order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. The research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. The sleep studies will take place in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home. Receives: Device: Forrest Snoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between the two following parameters: (1) Total time of snoring during sleep with the device ("Forest") (2) Total time of snoring during sleep without the device. Resulting value is in minutes.
Measured: 1 year
Secondary outcomes (5)
Snoring intensity at its peak, measured in decibels (dB). Resulting value is a number measured in dB Snoring intensity at its peak, measured in decibels (dB). Resulting value is a number measured in dB
Measured: 1 year
Number of obstructive events during sleep. Resulting value is an absolute number.
Measured: 1 year
Difference between the two following parameters: (1) Average oxygen saturation level with the device ("Forest") (2) Average oxygen saturation level without the device. Resulting value is in percents (%).
Measured: 1 year
Total time during which the oxygen saturation level is less than 90% during sleep with and without the device. Resulting value is in minutes
Measured: 1 year
Questionnaire: user experience (subjective) after a night with and without the device. Verbal description without scaling satisfaction.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2017 (estimated)
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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Sleeping
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952118
- Sponsor's protocol ID
- GES-ST-02-100
- Status last verified
- Oct 2016
- First submitted
- 25 Oct 2016
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Appliance for the Treatment of Snoring in Adult Subjects - A Pilot Study
- ClinicalTrials.gov ID
- NCT02952118
- Acronym / sponsor ID
- GES-ST-02-100
- Conditions
- Snoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- GE SleepingIndustry (pharma, biotech, devices)
- Study start
- Nov 2016
- Primary completion
- Nov 2017 (estimated)
- First posted
- 2 Nov 2016 (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.
This is an open, pilot study for adults ( age range of 20-70 years old), who suffer from snoring without obstructive sleep apnea (OSA) and no need for CPAP treatment: with standard diagnosis of sleep study or with minor sleep disorder (AHI of less than 15 events per hour). Patients with no OSA over the last year will sign an informed consent after receiving explanations from authorized physician (Professor Asher Tal). The patient will than undergo a sleep study using a mobile device PAT (Peripheral Arterial Tomography, Itamar Medical, Israel) ,an approved device in Israel, USA and many other European countries,, approved for use by the USA FDA). This sleep study is needed in order to rule out OSA, namely AHI of more than 15 events per hour of sleep.
The study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with PAT device, with snoring recording and without the "Forrest" epic device. In the second night the sleep study will be with PAT device, with snoring recording and with the "Forrest" epic device. The order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. The research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. The sleep studies will take place in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home.
Recordings over the nights with or without the "Forrest" epic device will be carried out at the patient's home, after verification that each patient sleeps alone in his/her room. The recording and data processing of snoring will be performed through the application "SNORLAB" on IPHONE 6 mobile device. Ambulatory sleep studies with PAT device will be carried out during two nights (with and without the Forrest Device) with most patients.
During the examination, respiratory index will be tested such as: obstructive respiratory events during sleep, oxygen saturation in blood at rest (measured non-invasively) during sleep: mean, lowest (nadir), and rate of time the patient sleeps in with less than 90% of oxygen saturation in blood.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| one night with the device and one night without the device. | Experimental | Device: Forrest Snoring deviceThe study duration with each patient will be 48 hours (two nights); at the first night the sleep study will be with PAT device, with snoring recording and without the "Forrest" epic device. In the second night the sleep study will be with PAT device, with snoring recording and with the "Forrest" epic device. The order of the sleep studies (with and without the epic device) will be randomly determined by computerized ahead prepared list. The research duration for patients that did not have a sleep study over the last year, will take place for 3 nights; the sleep study will be performed in order to make sure the patient does not suffer from obstructive respiratory disorder during sleep. The sleep studies will take place in a sleep laboratory (Millennium Sleep Labs LTD, Beer Sheva) or as an ambulatory study, at home. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patient age range : 20-70 years old.
- The patient / legal guardian able and willing to sign conscious written agreement.
- The patient / legal guardian able and willing to comply with the study protocol.
- The patient is suffering from snoring.
- The patient underwent a sleep study over the last year.
Key exclusion criteria (2 listed)
- The patient suffers from sleep apnea that requires CPAP treatment: more than 15 AHI per hour in a sleep study or due to significant background diseases.
- Patient less than 20 years old.
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 |
|---|---|---|
| Forrest Snoring device | Device | one night with the device and one night without the device. |
Primary outcome
Difference between the two following parameters: (1) Total time of snoring during sleep with the device ("Forest") (2) Total time of snoring during sleep without the device. Resulting value is in minutes.
Time frame: 1 year
5 secondary outcomes
Snoring intensity at its peak, measured in decibels (dB). Resulting value is a number measured in dB Snoring intensity at its peak, measured in decibels (dB). Resulting value is a number measured in dB
Time frame: 1 year
Number of obstructive events during sleep. Resulting value is an absolute number.
Time frame: 1 year
Difference between the two following parameters: (1) Average oxygen saturation level with the device ("Forest") (2) Average oxygen saturation level without the device. Resulting value is in percents (%).
Time frame: 1 year
Total time during which the oxygen saturation level is less than 90% during sleep with and without the device. Resulting value is in minutes
Time frame: 1 year
Questionnaire: user experience (subjective) after a night with and without the device. Verbal description without scaling satisfaction.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Forrest Snoring device in people with Snoring, run by GE Sleeping.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Nov 2016. 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?
Results are not available in the source record.
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?
Difference between the two following parameters: (1) Total time of snoring during sleep with the device ("Forest") (2) Total time of snoring during sleep without the device. Resulting value is in minutes. (time frame: 1 year). 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 2 Nov 2016.