Voice QualityNCT02828514
Nasal Resonance Change After Endoscopic Endonasal Transsphenoidal Skull Base Surgery: Analysis of Quality of Voice
An observational study of Voice Quality and Endoscopic Pituitary Surgery, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to determine nasal resonance change after endoscopic endonasal transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Voice Quality, Endoscopic Pituitary Surgery
- How many people
- 46 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2015to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent endoscopic endonasal transsphenoidal skull base surgery
Who may be able to join
- Patients who underwent endoscopic endonasal transsphenoidal skull base surgery
Who cannot join
- Patients under 18 year
- Patients cannot following command including loss of conscious
- Patients cannot speak including patient on tracheostomy tube
- Patients who has nasal tumor, nasal polyp, sinusitis
- Patients who has cleft lip cleft palate or submucosal cleft
- Patients who underwent adenotonsillectomy or palatoplasty in same setting with endoscopic pituitary surgery
Trial locations and contacts
1 site in 1 country.
Pornthep Kasemsiri, MD. contact
Cattleya Thongrong, MD. contact
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen University
Khon Kaen, Khon Kean, 40002
Pornthep Kasemsiri, MD, Pkasemsiri99@gamil.com
About this study
The purpose of this study is to determine nasal resonance change after endoscopic endonasal transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also.
- Conditions
- Voice Quality, Endoscopic Pituitary Surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal resonance change after endoscopic endonasal transsphenoidal surgery which was assessed by computer speech lab
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Voice QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pornthep Kasemsiri, Khon Kaen University
- Investigators
- Pornthep Kasemsiri, MD., Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828514
- Sponsor's protocol ID
- IN58314
- Status last verified
- Feb 2017
- First submitted
- 2 Jul 2016
- Last updated
- 3 Feb 2017
- Results posted
- No
Publications
Kasemsiri P, Duangthongphon P, Prathanee B, Thongrong C. Nasal resonance changes after endoscopic endonasal transsphenoidal skull base surgery: Analysis of voice quality. Laryngoscope Investig Otolaryngol. 2021 Nov 19;6(6):1275-1282. doi: 10.1002/lio2.701. eCollection 2021 Dec.
PubMed 34938862
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Resonance Change After Endoscopic Endonasal Transsphenoidal Skull Base Surgery: Analysis of Quality of Voice
- ClinicalTrials.gov ID
- NCT02828514
- Acronym / sponsor ID
- IN58314
- Conditions
- Voice Quality, Endoscopic Pituitary Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine nasal resonance change after endoscopic endonasal transsphenoidal skull base surgery. Furthermore, the quality of voice is assessed, also.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent endoscopic endonasal transsphenoidal skull base surgery
Key inclusion criteria (1 listed)
- Patients who underwent endoscopic endonasal transsphenoidal skull base surgery
Key exclusion criteria (6 listed)
- Patients under 18 year
- Patients cannot following command including loss of conscious
- Patients cannot speak including patient on tracheostomy tube
- Patients who has nasal tumor, nasal polyp, sinusitis
- Patients who has cleft lip cleft palate or submucosal cleft
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Nasal resonance change after endoscopic endonasal transsphenoidal surgery which was assessed by computer speech lab
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 34938862Kasemsiri P, Duangthongphon P, Prathanee B, Thongrong C. Nasal resonance changes after endoscopic endonasal transsphenoidal skull base surgery: Analysis of voice quality. Laryngoscope Investig Otolaryngol. 2021 Nov 19;6(6):1275-1282. doi: 10.1002/lio2.701. eCollection 2021 Dec.
Related trials for Voice Quality
Recruiting
Voices Illuminating Solutions for Outdoor Workers' Needs and Safety
Air Pollution Exposure
Recruiting
NHRI Intelligent Voice Interactive Platform for High-Quality Community Living Among Older Adults
Aging, Behavior
Recruiting
Impact of EDEN College Courses on the Quality of Life of Voice-Hearers
Hallucinations, Auditory
Not yet recruiting
THE EFFECT OF POSTURAL ALİGNMENT AND DEEP CERVICAL MUSCLE TRAINING ON VOICE FUNCTION IN OLDER ADULTS WITH PRESBYPHONIA
Presbyphonia, Deep Cervical Muscles
Active, not recruiting
Effects of Transcutaneous Vagus Nerve Stimulation in Parkinson´s Disease
Transcutaneous Vagal Nerve Stimulation (tVNS), Parkinson Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pornthep Kasemsiri, MD. contact
Cattleya Thongrong, MD. contact
Pornthep Kasemsiri, MD. principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Voice Quality and Endoscopic Pituitary Surgery, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pornthep Kasemsiri, MD. (Pkasemsiri99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal resonance change after endoscopic endonasal transsphenoidal surgery which was assessed by computer speech lab (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02828514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.