Obstructive Sleep ApneaNCT04726514
SleepFlexTM Treatment of Obstructive Sleep Apnea
A study testing SleepFlex in people with Obstructive Sleep Apnea, run by Berendo Scientific, LLC at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- SleepFlex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years and older
- Mild to moderate OSA, defined as AHI >10 - 30 events/hour, documented by polysomnogram or home sleep apnea test within 180 days prior to study enrollment
- Central or mixed disordered breathing events (≤25% of total number of events)
- Unable to tolerate or decline positive airway pressure therapy
- Body mass index ≤32 kg/m2
- Able to protrude tongue ≥20 mm beyond maxillary incisors
Show all 19Show fewer
- Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification
- No uncontrolled sleep disorder other than OSA such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder
- Absence of excessive daytime sleepiness, defined by Epworth Sleepiness Scale score >10
- No uncontrolled nasal obstruction
- Absence of moderate to severe mandibular insufficiency
- No previous surgery involving the oral cavity or pharynx other than tonsillectomy
- No previous radiation therapy to the head and neck
- No known neurologic, cardiac (other than hypertension controlled with a single medication), pulmonary, renal, hepatic, or psychiatric disorders
- No psychiatric diagnoses other than treated depression or mild anxiety
- Stable medication regimen for ≥1 month
- No acute illness or infection
- Ownership of personal smartphone with iOS or Android operating system
- No known hypersensitivity to any material of the SleepFlex devices
Who cannot join
- Unwilling or unable to provide informed written consent in English
- Pregnancy, breastfeeding, or plans to become pregnant
- Smoker (tobacco or recreational drugs) in the past month
- Alcohol consumption, averaged over the previous month, greater than 2 alcoholic beverages per day
- Significant vision or hearing problems
- Unwilling or incapable of returning for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
- Any other reason the investigator determines as being unfit for study participation
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA
- Conditions
- Obstructive Sleep Apnea
- Being tested
- SleepFlex
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SleepFlexDevice
SleepFlex Program
| Study group | Role | What they receive |
|---|---|---|
| SleepFlex Treatment | Experimental | Not described Receives: Device: SleepFlex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events
Number of participants with absence of serious adverse events related to the SleepFlex system.
Measured: 12 weeks
Change in the Apnea-hypopnea Index (AHI)
Change in the apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test. Apneas are defined by >=80% reduction in airflow for >= 10 seconds in the presence of respiratory effort. Hypopneas are defined by >=50% reduction in airflow with oxygen desaturation of >=3% in the presence of respiratory effort. The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of recording time. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe.
Measured: 12 weeks
Secondary outcomes (1)
Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia
Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start20 Jul 2021
- Primary completion1 Apr 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstructive Sleep ApneaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Berendo Scientific, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04726514
- Sponsor's protocol ID
- 0100
- Status last verified
- Jun 2023
- First submitted
- 23 Jan 2021
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SleepFlexTM Treatment of Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04726514
- Acronym / sponsor ID
- 0100
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Berendo Scientific, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SleepFlex Treatment | Experimental | Device: SleepFlex |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 21 years and older
- Mild to moderate OSA, defined as AHI >10 - 30 events/hour, documented by polysomnogram or home sleep apnea test within 180 days prior to study enrollment
- Central or mixed disordered breathing events (≤25% of total number of events)
- Unable to tolerate or decline positive airway pressure therapy
- Body mass index ≤32 kg/m2
Key exclusion criteria (7 listed)
- Unwilling or unable to provide informed written consent in English
- Pregnancy, breastfeeding, or plans to become pregnant
- Smoker (tobacco or recreational drugs) in the past month
- Alcohol consumption, averaged over the previous month, greater than 2 alcoholic beverages per day
- Significant vision or hearing problems
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 |
|---|---|---|
| SleepFlexSleepFlex Program | Device | SleepFlex Treatment |
Primary outcome
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events
Time frame: 12 weeks
Number of participants with absence of serious adverse events related to the SleepFlex system.
Change in the Apnea-hypopnea Index (AHI)
Time frame: 12 weeks
Change in the apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test. Apneas are defined by >=80% reduction in airflow for >= 10 seconds in the presence of respiratory effort. Hypopneas are defined by >=50% reduction in airflow with oxygen desaturation of >=3% in the presence of respiratory effort. The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of recording time. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and >= 30/h = severe.
1 secondary outcome
Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SleepFlex in people with Obstructive Sleep Apnea, run by Berendo Scientific, LLC at 1 site in United States.
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 19 inclusion and 7 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 22 Jun 2023. 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 States. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 22 Jun 2023.