CClinicalTrials.gg
Sign In
CompletedNCT04726514Updated Jun 22, 2023Results posted

SleepFlexTM Treatment of Obstructive Sleep Apnea

An interventional study of SleepFlex in Obstructive Sleep Apnea, sponsored by Berendo Scientific, LLC. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.

Sponsored by Berendo Scientific, LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA

02

Conditions studied

  • Obstructive Sleep Apnea
03

In context

Apnea

1,423 studies on the registry are indexed under Apnea; 160 are open to participants now.

This study's enrollment of 10 is below the median of 51 across 966 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

This is the only study on the registry with Berendo Scientific, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    SleepFlex Treatment

    Device: SleepFlex

Interventions

  • DeviceSleepFlex

    SleepFlex Program

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 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.

    Time frame: 12 weeks

Other outcomes

  1. Change in Supine AHI

    Change in the supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The supine position is defined by sleeping on one's back.

    Time frame: 12 weeks

  2. Change in Non-supine AHI

    Change in the non-supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The non-supine position is defined by sleeping in body positions other than one's back. Body position information is collected by the home sleep apnea test, and position-specific information is calculated.

    Time frame: 12 weeks

07

Results

Posted Jun 22, 2023

Participant flow

medical office

Participant flow — Overall Study
MilestoneSleepFlex Treatment
Started10
Completed8
Not completed2

Outcome measures

PrimaryNumber of Participants With Freedom From SleepFlex-related Serious Adverse Events

Number of participants with absence of serious adverse events related to the SleepFlex system.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events
ParticipantsSleepFlex Treatment
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events10
PrimaryChange 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.

Time frame:
12 weeks
Reported as:
Mean · events/hour
Change in the Apnea-hypopnea Index (AHI)
events/hourSleepFlex Treatment
Change in the Apnea-hypopnea Index (AHI)2.9 ± 3.5
SecondaryNumber 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.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia
ParticipantsSleepFlex Treatment
Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia0
Other pre-specifiedChange in Supine AHI

Change in the supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The supine position is defined by sleeping on one's back.

Time frame:
12 weeks
Reported as:
Mean · events/hour
Change in Supine AHI
events/hourSleepFlex Treatment
Change in Supine AHI5.7 ± 6.1
Other pre-specifiedChange in Non-supine AHI

Change in the non-supine apnea-hypopnea index (AHI) on post-treatment vs. pre-treatment home sleep apnea test.The Apnea-hypopnea index (AHI) is the sum of the apneas and hypopneas divided by the hours of sleep. AHI values are typically categorized as 5-15/hr = mild; 15-30/hr = moderate; and \>= 30/h = severe. The non-supine position is defined by sleeping in body positions other than one's back. Body position information is collected by the home sleep apnea test, and position-specific information is calculated.

Time frame:
12 weeks
Reported as:
Mean · events/hour
Change in Non-supine AHI
events/hourSleepFlex Treatment
Change in Non-supine AHI0.5 ± 4.6

Adverse events

Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
SleepFlex Treatment0/10 (0%)0/10 (0%)0/10 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)SleepFlex Treatment
<=18 years0
Between 18 and 65 years8
>=65 years2
Sex: Female, Male
Sex: Female, Male(Participants)SleepFlex Treatment
Female5
Male5
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SleepFlex Treatment
Hispanic or Latino0
Not Hispanic or Latino10
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SleepFlex Treatment
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American1
White6
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)SleepFlex Treatment
United States10
apnea-hypopnea index
apnea-hypopnea index(events/hour)SleepFlex Treatment
Mean15.1 ± 5.1
08

Study locations

1 site
  • Tower Sleep Medicine
    Los Angeles, California 90048, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 15, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04726514
Lead sponsor
Berendo Scientific, LLC
Responsible party
Sponsor
First posted
Jan 27, 2021
Start date
Jul 20, 2021
Primary completion
Apr 1, 2022
Completion
May 31, 2022
Results posted
Jun 22, 2023
Last update
Jun 22, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Apnea→

Start the discussion