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

Not Applicable

Completed

• Conditions: Occupational Therapy; Anosmia; Brain Injuries, Traumatic
• Interventions: Behavioral: olfactory rehabilitation

• Registration Number: NCT04957563
• Lead Sponsor: Cristina Gomez Calero

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

Study Timeline

• Study Start: 2009-10-20
• Primary Completion: 2014-10-20
• Study Completion: 2014-10-20
• Status Verified: 2021-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-30
• Last Update Submitted: 2021-06-30
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental rehabilitation	olfactory rehabilitation	recived olfactory rehabilitation

Primary Outcome Measures

Name	Time	Method
CCCRC	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 Outcome Measures

Name	Time	Method
RSDI	6 months	Rhinosinusitis Disability Index. The Rhinosinusitis Disability Index (RSDI) is a 30-item, Likert-scale survey consisting of three individual subscales that include the physical, functional, and emotional domains. Total scores range between 0-120. Higher RSDI total and domain scores imply a higher impact of disease

Trial Locations

Locations (1)

Hospital Universitario Fundación Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain