Trial Outcomes & Findings for AspiRATE: Novel Intervention to Acoustically Detect Silent Aspiration in Acquired Dysphagia. (NCT NCT03676582)

Results Overview

Presence or absence of matter passing between or below the vocal cords during swallowing, particularly in the absence of cough reflex stimulation - novel intervention to acoustically detect silent aspiration in patients

Recruitment status

COMPLETED

Target enrollment

25 participants

Primary outcome timeframe

1 hour

Results posted on

2025-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Stroke Patients Stroke patients - with acquired dysphagia
Overall Study STARTED	25
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Stroke Patients n=25 Participants Stroke patients - with acquired dysphagia
Age, Categorical <=18 years	0 Participants n=25 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=25 Participants
Age, Categorical >=65 years	20 Participants n=25 Participants
Sex: Female, Male Female	10 Participants n=25 Participants
Sex: Female, Male Male	15 Participants n=25 Participants
Region of Enrollment United Kingdom	25 participants n=25 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: Stroke patients with acquired dysphagia undergoing videofluoroscopy

Presence or absence of matter passing between or below the vocal cords during swallowing, particularly in the absence of cough reflex stimulation - novel intervention to acoustically detect silent aspiration in patients

Outcome measures

Outcome measures
Measure	Swallowing Events n=16 Participants Swallowing events of Stroke patients - with acquired dysphagia
Presence or Absence of Aspiration	42 swallowing events with aspiration

Adverse Events

Stroke Patients

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

Lise Sproson

Sheffield Teaching Hospitals NHS Trust

Phone: 07753827428

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place