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Clinical Trials/NCT04957563
NCT04957563
Completed
Not Applicable

Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia

Cristina Gomez Calero1 site in 1 country40 target enrollmentOctober 20, 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anosmia
Sponsor
Cristina Gomez Calero
Enrollment
40
Locations
1
Primary Endpoint
CCCRC
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The aim of our study was to compare the recovery of smell in people suffering posttraumatic olfactory impairment following a systematic olfactory rehabilitation performed by occupational therapists to natural recovery in a control posttraumatic group of patients.

Detailed Description

Forty participants started the study: 20 for the control group and 20 for the treatment group. The mean of the time span between the traumatic event and the first visit in the rehabilitation group was longer than 22 months, time enough to wait any kind of spontaneous recovery. In order to establish correct comparisons, the investigators analyzed whether both groups of participants (control group and treatment group) were homogeneous or not regarding the age, gender, time span between the traumatic event and the first visit to the office, brain damage and loss of conscience. Investigators administered visual analogic scale (VAS), CCCRC olfactory test and quality of life questionnaire (RSDI) to both groups at the beginning of the study and 12 months late

Registry
clinicaltrials.gov
Start Date
October 20, 2009
End Date
October 20, 2014
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Cristina Gomez Calero
Responsible Party
Sponsor Investigator
Principal Investigator

Cristina Gomez Calero

PhD. Professor. Occupational therapist

Universidad Rey Juan Carlos

Eligibility Criteria

Inclusion Criteria

  • Olfactory loss participants from institution to the Smell \& Tast Office, Otorhinolaryngology Unit, Hospital Universitario Fundación Alcorcón.
  • All participants provided written informed consent

Exclusion Criteria

  • No sign informed consent

Outcomes

Primary Outcomes

CCCRC

Time Frame: 6 months

the Connecticut Chemosensorial Clinical Research Centre test (CCCRC) Cain, W.S., Goodspeed, R.B., Gent, J.F. \& Leonard, G. (1988). Evaluation of olfactory dysfunction in the Connecticut Clinical Chemosensory Research Centre. Laryngoscope, 98:83-8. https://doi.org/10.1288/00005537-198801000-00017

Secondary Outcomes

  • RSDI(6 months)

Study Sites (1)

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