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

Sponsor

Cristina Gomez Calero (Other)

Overall Status

Completed

CT.gov ID

NCT04957563

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anosmia Occupational Therapy Brain Injuries, Traumatic	Behavioral: olfactory rehabilitation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

control group and experimental groupcontrol group and experimental group

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 20, 2009

Actual Primary Completion Date :

Oct 20, 2014

Actual Study Completion Date :

Oct 20, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: experimental rehabilitation recived olfactory rehabilitation	Behavioral: olfactory rehabilitation treatment for improve olfactory function
No Intervention: control withouth olfactory rehabilitation

Arm

Intervention/Treatment

Experimental: experimental rehabilitation

recived olfactory rehabilitation

Behavioral: olfactory rehabilitation

treatment for improve olfactory function

No Intervention: control

withouth olfactory rehabilitation

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid	Spain

Sponsors and Collaborators

Cristina Gomez Calero

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cristina Gomez Calero, PhD. Professor. Occupational therapist, Universidad Rey Juan Carlos

ClinicalTrials.gov Identifier:

NCT04957563

Other Study ID Numbers:

09/79 (HUFA)

First Posted:

Jul 12, 2021

Last Update Posted:

Jul 12, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Cristina Gomez Calero, PhD. Professor. Occupational therapist, Universidad Rey Juan Carlos

occupational therapy

anosmia

brain injuries, traumatic

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Anosmia

Study Results

No Results Posted as of Jul 12, 2021