Trial Outcomes & Findings for SleepFlexTM Treatment of Obstructive Sleep Apnea (NCT NCT04726514)

NCT ID: NCT04726514

Last Updated: 2023-06-22

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

12 weeks

Results posted on

2023-06-22

Participant Flow

medical office

Participant milestones

Participant milestones
Measure	SleepFlex Treatment SleepFlex: SleepFlex Program
Overall Study STARTED	10
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SleepFlexTM Treatment of Obstructive Sleep Apnea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SleepFlex Treatment n=10 Participants SleepFlex: SleepFlex Program
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants
apnea-hypopnea index	15.1 events/hour STANDARD_DEVIATION 5.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	SleepFlex Treatment n=10 Participants SleepFlex: SleepFlex Program
Number of Participants With Freedom From SleepFlex-related Serious Adverse Events	10 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SleepFlex Treatment n=7 Participants SleepFlex: SleepFlex Program
Change in the Apnea-hypopnea Index (AHI)	2.9 events/hour Standard Deviation 3.5

SECONDARY outcome

Timeframe: 12 weeks

Number of participants with development of the following potential side effects: mouth, throat, or neck pain; dysphagia. This was assessed repeatedly throughout the study.

Outcome measures

Outcome measures
Measure	SleepFlex Treatment n=10 Participants SleepFlex: SleepFlex Program
Number of Participants With Development of Side Effects: Mouth, Throat, or Neck Pain; Dysphagia	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

Population: Participants who completed study

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.

Outcome measures

Outcome measures
Measure	SleepFlex Treatment n=7 Participants SleepFlex: SleepFlex Program
Change in Supine AHI	5.7 events/hour Standard Deviation 6.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 weeks

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.

Outcome measures

Outcome measures
Measure	SleepFlex Treatment n=7 Participants SleepFlex: SleepFlex Program
Change in Non-supine AHI	0.5 events/hour Standard Deviation 4.6

Adverse Events

SleepFlex Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Eric Kezirian

Berendo Scientific, LLC

Phone: 4152358706

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place