Trial Outcomes & Findings for Prospective Study to Evaluate Outcomes From Transoral BOT Resection for OSAHS (NCT NCT01107795)

Last Updated: 2020-01-06

Results Overview

Improvement in Apnea Hypopnea Index (AHI) score, as measured by a polysomnogram sleep study. The AHI score is the number of apnea events per hour, with a lower score indicating mild sleep apnea and a higher score indicating severe sleep apnea. An improved AHI score would be a lower score at 6 months than at 3 months and baseline.

Recruitment status

TERMINATED

Target enrollment

41 participants

Primary outcome timeframe

Baseline, 3 months, 6 months

Results posted on

2020-01-06

Participant Flow

Participant milestones

Participant milestones
Measure	Transoral BOT Participants who received transoral base of tongue surgery as treatment for OASHS.
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participants with no recorded AHI score were considered eligible for surgery based on the RDI (Respiratory Disturbance Index) score. There is no way to convert an RDI score to an AHI score without access to the original sleep study data, as RDI takes into account all respiratory-effort related arousals.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transoral BOT n=41 Participants Participants who received transoral base of tongue surgery as treatment for OASHS.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	10 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	41 participants n=5 Participants
Number of Participants Stratified by Apnea Hypopnea Index (AHI) score Mild apnea (AHI score of 0 to 14.99)	8 participants n=5 Participants • Participants with no recorded AHI score were considered eligible for surgery based on the RDI (Respiratory Disturbance Index) score. There is no way to convert an RDI score to an AHI score without access to the original sleep study data, as RDI takes into account all respiratory-effort related arousals.
Number of Participants Stratified by Apnea Hypopnea Index (AHI) score Moderate apnea (AHI score of 15 to 29.99)	5 participants n=5 Participants • Participants with no recorded AHI score were considered eligible for surgery based on the RDI (Respiratory Disturbance Index) score. There is no way to convert an RDI score to an AHI score without access to the original sleep study data, as RDI takes into account all respiratory-effort related arousals.
Number of Participants Stratified by Apnea Hypopnea Index (AHI) score Severe apnea (AHI score of 30 or higher)	17 participants n=5 Participants • Participants with no recorded AHI score were considered eligible for surgery based on the RDI (Respiratory Disturbance Index) score. There is no way to convert an RDI score to an AHI score without access to the original sleep study data, as RDI takes into account all respiratory-effort related arousals.
Number of Participants Stratified by Apnea Hypopnea Index (AHI) score no recorded AHI score available	11 participants n=5 Participants • Participants with no recorded AHI score were considered eligible for surgery based on the RDI (Respiratory Disturbance Index) score. There is no way to convert an RDI score to an AHI score without access to the original sleep study data, as RDI takes into account all respiratory-effort related arousals.

PRIMARY outcome

Timeframe: Baseline, 3 months, 6 months

Population: Participant attrition rate was very high; no data were collected.

Outcome measures

Outcome data not reported

Adverse Events

Transoral BOT

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Transoral BOT n=41 participants at risk Participants who received transoral base of tongue surgery as treatment for OASHS.
Nervous system disorders syncope	2.4% 1/41 • 6 months
Respiratory, thoracic and mediastinal disorders laryngeal edema	2.4% 1/41 • 6 months

Other adverse events

Other adverse events
Measure	Transoral BOT n=41 participants at risk Participants who received transoral base of tongue surgery as treatment for OASHS.
General disorders pain	4.9% 2/41 • 6 months
Injury, poisoning and procedural complications postoperative hemorrhage	2.4% 1/41 • 6 months
Respiratory, thoracic and mediastinal disorders aspiration	2.4% 1/41 • 6 months

Additional Information

Dr. Kirk Withrow

University of Alabama at Birmingham

Phone: (205) 801-7874

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place