Trial Outcomes & Findings for Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device (NCT NCT01857713)

Results Overview

The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

4 Weeks minus Baseline

Results posted on

2015-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	Fitted With Reza Band UES Assist Device Patients were fitted with the Reza Band UES Assist Device and served as their own control. Baseline measures were comported to follow-up visit measures.
Overall Study STARTED	95
Overall Study COMPLETED	89
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Extraesophageal Reflux With the Reza Band UES Assist Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fitted With Reza Band UES Assist Device n=95 Participants Patients were their own control and Fitted with Reza Band UES Assist Device. Results were obtained by measuring symptoms at baseline and then compared at each of the prescribed follow-up visits.
Age, Continuous	48.8 Years STANDARD_DEVIATION 13.7 • n=93 Participants
Sex: Female, Male Female	66 Participants n=93 Participants
Sex: Female, Male Male	29 Participants n=93 Participants
Race/Ethnicity, Customized African American	4 participants n=93 Participants
Race/Ethnicity, Customized Caucasian	77 participants n=93 Participants
Race/Ethnicity, Customized Hispanic	8 participants n=93 Participants
Race/Ethnicity, Customized Asian	1 participants n=93 Participants
Race/Ethnicity, Customized Other	1 participants n=93 Participants
Race/Ethnicity, Customized Not Reported	4 participants n=93 Participants
Region of Enrollment United States	95 participants n=93 Participants
Weight	160.0 pounds STANDARD_DEVIATION 31.3 • n=93 Participants
BMI	25.5 kg/m^2 STANDARD_DEVIATION 4.2 • n=93 Participants

PRIMARY outcome

Timeframe: 4 Weeks minus Baseline

The RSI is a validated nine-item patient-administered outcome questionnaire designed to document symptoms and severity. Patients are asked to rate how nine problems have affected them on a scale of 0 (no problem) to 5 (severe problem), with a maximum total score of 45).

Outcome measures

Outcome measures
Measure	Reza Band n=89 Participants Participants fitted with Reza Band UES Assist Device
Percent Change in the Reflux Symptom Index (RSI) at 4 Weeks	-54.3 Per Cent Change Standard Deviation 27.1

PRIMARY outcome

Timeframe: 4 Week Follow-up

Population: Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).

Adverse reactions reported were evaluated with the frequency and percent of subjects of each reaction being summarized by severity and by relationship to the Reza Band UES Assist Device.

Outcome measures

Outcome measures
Measure	Reza Band n=95 Participants Participants fitted with Reza Band UES Assist Device
Primary Safety	58.6 % Reporting Any Adverse Event

SECONDARY outcome

Timeframe: 4 Weeks minus Baseline

Population: Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).

The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Outcome measures

Outcome measures
Measure	Reza Band n=89 Participants Participants fitted with Reza Band UES Assist Device
SF-36 Short Form Health Survey - 4 Week Follow-up Score Compared to Baseline Score	0.56 Change in Units on a Scale Standard Deviation 6.88

SECONDARY outcome

Timeframe: 4 Weeks minus Baseline

Population: Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).

The FOSQ is a self-report measure (0-4 for each of 30 questions) designed to assess the impact of disorders of excessive sleepiness (DOES) on multiple activities of everyday living that includes areas of physical, mental and social functioning. Scores can range from 0 (worst possible outcome) to 120 (best possible outcome). Zero (0) is defined as not doing that specific activity for other reasons.

Outcome measures

Outcome measures
Measure	Reza Band n=89 Participants Participants fitted with Reza Band UES Assist Device
Functional Outcomes of Sleep Questionnaire (FOSQ)	0.80 Change in Units on a Scale Standard Deviation 11.04

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks

Patients provide their perception of the device at the end of the study.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 4 Weeks

Investigators provide their perception of the device at the end of the study.

Outcome measures

Outcome data not reported

Adverse Events

Fitted With Reza Band UES Assist Device

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Fitted With Reza Band UES Assist Device n=95 participants at risk Patients were fitted with the Reza Band UES Assist Device and were their own controls. Baseline measures were compared to each of the prescribed follow-up visit measures.
Social circumstances Reza Band Comfort	1.1% 1/95 • Adverse events were collected from patient diaries as well as at the time of follow-up visits by the investigators. The events were noted throughout the length of the study, 4 weeks from the initial fitting of the Reza Band
Respiratory, thoracic and mediastinal disorders Post Nasal Drip	1.1% 1/95 • Adverse events were collected from patient diaries as well as at the time of follow-up visits by the investigators. The events were noted throughout the length of the study, 4 weeks from the initial fitting of the Reza Band
General disorders Temporomandibular Joint Disorders	1.1% 1/95 • Adverse events were collected from patient diaries as well as at the time of follow-up visits by the investigators. The events were noted throughout the length of the study, 4 weeks from the initial fitting of the Reza Band
Musculoskeletal and connective tissue disorders Bruised neck	1.1% 1/95 • Adverse events were collected from patient diaries as well as at the time of follow-up visits by the investigators. The events were noted throughout the length of the study, 4 weeks from the initial fitting of the Reza Band
Gastrointestinal disorders Biopsies due to Colonoscopy	1.1% 1/95 • Adverse events were collected from patient diaries as well as at the time of follow-up visits by the investigators. The events were noted throughout the length of the study, 4 weeks from the initial fitting of the Reza Band
General disorders Fell Down	1.1% 1/95 • Adverse events were collected from patient diaries as well as at the time of follow-up visits by the investigators. The events were noted throughout the length of the study, 4 weeks from the initial fitting of the Reza Band
Ear and labyrinth disorders Throat infection	1.1% 1/95 • Adverse events were collected from patient diaries as well as at the time of follow-up visits by the investigators. The events were noted throughout the length of the study, 4 weeks from the initial fitting of the Reza Band

Additional Information

James Miller

Somna Therapeutics, L.L.C.

Phone: 262-345-5553

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place