NCT01009632

Brief Summary

The purpose of this study is to explore quantitatively the hypothesis that "resonant voice," may enhance recovery from acute laryngeal phonotrauma, based on molecular assays from human laryngeal secretions and secondarily, clinical tests.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
Last Updated

November 9, 2009

Status Verified

November 1, 2009

Enrollment Period

1.1 years

First QC Date

November 5, 2009

Last Update Submit

November 6, 2009

Conditions

Acute Phonotrauma

Outcome Measures

Primary Outcomes (1)

  • Biomarkers in laryngeal secretions

    Up to 24-hour post-baseline

Secondary Outcomes (3)

  • Phonation Threshold Pressure (PTP)

    Up to 24-hour post baseline

  • Direct Magnitude Estimations of phonatory effort (DME)

    Up to 24-hour post baseline

  • Visual-perceptual ratings of the larynx

    Up to 24-hour post baseline

Study Arms (3)

Voice rest

EXPERIMENTAL
Behavioral: Voice rest

Resonant voice exercise

EXPERIMENTAL
Behavioral: Resonant voice

Spontaneous speech

EXPERIMENTAL
Behavioral: Spontaneous speech

Interventions

Resonant voiceBEHAVIORAL

4-hr of resonant voice exercise

Resonant voice exercise
Voice restBEHAVIORAL

4-hr of complete refrain from any voice use

Voice rest
Spontaneous speechBEHAVIORAL
Also known as: 4-hr of conversational (normal) voice use
Spontaneous speech

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • males and females who have had voice training and feel they are able to produce loud voice safely;
  • ages 18-49;
  • generally healthy;
  • normal hearing bilaterally at 20 dB to 8,000 Hz; and
  • demonstrated ability to produce "resonant voice" during training as determined by the examiner perceptually.

You may not qualify if:

  • current chronic voice problems;
  • current medications that are determined to possibly influence voice (e.g. diuretics, decongestants);
  • heightened gag reflex;
  • small nasal passage;
  • deviated septum; and
  • known or suspected allergy to anesthetics.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univesity of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Study Officials

  • Katherine Verdolini Abbott, Ph.D.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 9, 2009

Study Start

February 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

November 9, 2009

Record last verified: 2009-11

Locations

US(1)