Sleep Apnea SyndromePhase 1/2NCT00942669
Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG)
A Phase 1/2 study testing SleepStrip OTC(TM) in people with Sleep Apnea Syndrome, run by Scientific Laboratory Products, Ltd. at 1 site in Israel.
Trial summary
The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndrome
- What is being tested?
- SleepStrip OTC(TM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Feb 2012
- Phase
- Phase 1/2
- 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
- Male or Female participants, 18 years of age or older at time of enrollment.
- Participants who present at the Technion Sleep Disorder Center for a PSG test, and who are willing comply with study procedures.
- Participants who are willing to sign a Written.
Who cannot join
- Participant has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
- Participant has facial hair or any other skin problem that may hinder proper application of the device on destined facial area.
- Participant is suffering from a respiratory-track infection or a runny nose at enrollment.
- Participant is unable to comprehend the purpose of the study as stated in the participant consent form.
- Participant is unable to comply with the technical requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Center, Open, Equivalence, Two Phase Study Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG) Study.
The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.
Read the detailed description
A prospective, single center two phase study to evaluate the validity and the predictability of the SleepStrip OTCTM in screening for SAS, as compared to the reference method, an in-lab, full night, attended Polysomnographic (PSG) Study.
The study will consist of two phases:
I: Optimization Phase:will be performed at the Clinic; 20 participants will be enrolled. Each participant will be connected simultaneously to the SleepStrip OTC(TM) and to the standard lab sensors and recorder. This phase is intended to allow SLP to optimize the analysis parameters for optimal performance and will be considered as a pilot phase.
II: Equivalence phase: At least 180 participants will be enrolled. All participants will receive the SleepStrip OTC(TM) for a night test at home, before or after undergoing an independent PSG test at the Sleep lab. Out of 180 participants, at least 26 participants will receive two SleepStrip OTC(TM) devices for two consecutive night tests at home. The remaining participants will receive one SleepStrip OTC(TM) for one night test.
- Conditions
- Sleep Apnea Syndrome
- Being tested
- SleepStrip OTC(TM)
- Keywords
- Sleep Apnea Syndrome, SAS, SleepStrip OTC
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepStrip OTC(TM)Device
Also called SleepStrip OTC, SAS, Sleep Apnea, PSG
self contained SAS screening device
| Study group | Role | What they receive |
|---|---|---|
| SleepStrip OTC(TM) | Experimental | Participants will receive the SleepStrip OTC(TM) for a night (or two) test at home, before or after undergoing an independent PSG test at the Sleep lab. The reading of both methods will be analyzed. Receives: Device: SleepStrip OTC(TM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses
Measured: The data will be analyzed after conclusion of tests of 200 home studies, no later than June 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionNov 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea SyndromeStudies 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scientific Laboratory Products, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giora Pillar, Prof., Principal investigator, Technion Sleep Disorders Center, Rambam Medical Centaer, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942669
- Sponsor's protocol ID
- SS-OTC-346 CTIL
- Status last verified
- Jun 2012
- First submitted
- 11 Jul 2009
- Last updated
- 7 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center, Open, Equivalence, Two Phase Study Comparing the Sleep Strip OTC™ Accuracy in Screening for Sleep Apnea Syndrome Against the Reference Method, an In-lab Full Night Polysomnographic (PSG) Study.
- ClinicalTrials.gov ID
- NCT00942669
- Acronym / sponsor ID
- SS-OTC-346 CTIL
- Conditions
- Sleep Apnea Syndrome
- Keywords
- Sleep Apnea Syndrome, SAS, SleepStrip OTC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Scientific Laboratory Products, Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Nov 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Jul 2009 (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.
The primary purpose of this study is to demonstrate the equivalence of the new Sleep Strip OTC(TM) compared to the reference method of an in-lab, attended full-night polysomnographic (PSG) study.
Detailed description
A prospective, single center two phase study to evaluate the validity and the predictability of the SleepStrip OTCTM in screening for SAS, as compared to the reference method, an in-lab, full night, attended Polysomnographic (PSG) Study.
The study will consist of two phases:
I: Optimization Phase:will be performed at the Clinic; 20 participants will be enrolled. Each participant will be connected simultaneously to the SleepStrip OTC(TM) and to the standard lab sensors and recorder. This phase is intended to allow SLP to optimize the analysis parameters for optimal performance and will be considered as a pilot phase.
II: Equivalence phase: At least 180 participants will be enrolled. All participants will receive the SleepStrip OTC(TM) for a night test at home, before or after undergoing an independent PSG test at the Sleep lab. Out of 180 participants, at least 26 participants will receive two SleepStrip OTC(TM) devices for two consecutive night tests at home. The remaining participants will receive one SleepStrip OTC(TM) for one night test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SleepStrip OTC(TM) | Experimental | Device: SleepStrip OTC(TM)Participants will receive the SleepStrip OTC(TM) for a night (or two) test at home, before or after undergoing an independent PSG test at the Sleep lab. The reading of both methods will be analyzed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or Female participants, 18 years of age or older at time of enrollment.
- Participants who present at the Technion Sleep Disorder Center for a PSG test, and who are willing comply with study procedures.
- Participants who are willing to sign a Written.
Key exclusion criteria (5 listed)
- Participant has a clinically significant untreated chronic disease which may unable him/ her to participate in the study.
- Participant has facial hair or any other skin problem that may hinder proper application of the device on destined facial area.
- Participant is suffering from a respiratory-track infection or a runny nose at enrollment.
- Participant is unable to comprehend the purpose of the study as stated in the participant consent form.
- Participant is unable to comply with the technical requirements of the study.
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 |
|---|---|---|
| SleepStrip OTC(TM)Also: SleepStrip OTC, SAS, Sleep Apnea, PSGself contained SAS screening device | Device | SleepStrip OTC(TM) |
Primary outcome
Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses
Time frame: The data will be analyzed after conclusion of tests of 200 home studies, no later than June 2010
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 7 Jun 2012.
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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.
Giora Pillar, Prof. principal investigator
Technion Sleep Disorders Center, Rambam Medical Centaer, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SleepStrip OTC(TM) in people with Sleep Apnea Syndrome, run by Scientific Laboratory Products, Ltd. at 1 site in Israel.
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 3 inclusion and 5 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 7 Jun 2012. 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 Israel. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Paired T-test or signed-rank test; McNemar's test; Sensitivity Analyses (time frame: The data will be analyzed after conclusion of tests of 200 home studies, no later than June 2010). 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 7 Jun 2012; AzTrials last refreshed its copy on 6 Nov 2026.