Hearing Impaired ChildrenNCT04691830
Adaptation of a Rehabilitation Program for Prosody and Its Application on Egyptian Hearing Impaired Children
A study testing Prosody treatment program and Traditional auditory and language rehabilitation in people with Hearing Impaired Children, run by Sara Magdy Ibrahim at 1 site in Egypt.
Trial summary
Prosody is the melody and rhythm of speech, it is used to refer to the supra segmental aspects of speech including pitch, loudness and duration. Variations in these features achieve different prosodic functions and are perceived by the listener as meaningful changes. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Hearing Impaired Children
- What is being tested?
- Prosody treatment program and Traditional auditory and language rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Feb 2019to 16 Feb 2020
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Hearing impaired children of both sexes, in the preschool age (from 3 to 6 years), and school age (6 to 18 years).
- Children using auditory verbal communication.
- Children with moderately severe or severe up to profound sensorineural hearing loss in unaided conditions, fitted with hearing aids or cochlear implant devices with good benefit (aided hearing threshold less than 40 dB across all frequencies).
Who cannot join
- Children with intellectual disability.
- Children with brain damage.
- Children with additional sensory deprivation (impaired vision).
- Psychiatric problems (example; ASD).
- Motor speech disorders (example: apraxia, dysarthria).
Trial locations and contacts
1 site in 1 country.
About this study
Prosody is the melody and rhythm of speech, it is used to refer to the supra segmental aspects of speech including pitch, loudness and duration. Variations in these features achieve different prosodic functions and are perceived by the listener as meaningful changes. The role of prosody in language acquisition and effective communication is documented in research. Nevertheless, prosodic intervention in children with hearing impairment received less attention compared to other speech and language areas.
The aim of this study is to adapt the "prosody treatment program", an evidence based rehabilitation program, and to detect the efficacy of its activities in improving the prosodic skills of Egyptian hearing impaired children.
The "prosody treatment program" is an evidence-based practice targeting receptive and expressive prosodic skills in addition to speech production, intelligibility, pragmatics and phonology. The program is applied using a systematic approach of providing cues following the principles adapted from dynamic temporal and tactile cueing (DTTC) for speech motor learning to help accelerate the child's learning of the prosodic skills targeted in this program. The program was translated to Arabic and adapted to be suitable for the Egyptian children.
Read the detailed description
Prosody has an important role in several areas of communicative functions including : grammatical, pragmatic, affective and/or indexical functions. Prosodic abnormalities extend across a wide range of communication disorders. Intact functioning auditory system has a fundamental role in language acquisition and development. Children receive the speech of others as a source of linguistic input which is considered their target and they gradually modify their productions using their own auditory feedback to reach the target utterance.
Hearing impairment early in life deprives the child of the source of their linguistic input affecting various aspects of speech and language development. Speech production of the hearing impaired is characterized by various segmental and suprasegmental errors.
Case studies show that interventions targeting prosody can modify prosody in young children with speech and language impairments. Multiple problems of prosody , language, speech and voice are found in individuals with prosodic impairments ,therefore it is challenging to develop treatment protocols addressing prosody .There are only few published interventions targeting prosody .
Due to lack of well structured comprehensive Arabic programs targeting prosody , this work was dedicated towards adaptation of "prosody treatment program" a remediation program targeting receptive and expressive prosodic skills and its application on hearing impaired children .The proposed program targets two levels: preschool and school aged children.
The aim of this work was to adapt the "prosody treatment program" program and apply its activities in cases of hearing impairment to detect its efficacy in improvement of prosodic skills in Egyptian hearing impaired children fitted with hearing aids or cochlear implant devices.
This study was conducted on 55 children with hearing impairment attending the Unit of Phoniatrics , in the outpatient clinic of Alexandria Main University hospital. Sample size was calculated using two proportions power analysis in NCSS and PASS program a minimum sample size required to detect the efficacy of the "prosody treatment program" in improvement of prosodic skills of Egyptian hearing impaired children and to detect a difference of 0.5 that achieve 80% power with a target significance level at 5%.
The proposed program is based on " prosody treatment program", a program targeting receptive and expressive prosodic skills. It includes activities targeting loudness , word stress ,syllable stress ,pitch ,question inflections ,emotions ,sarcasm ,rhythm ,chunking, and speaking rate . The program was adapted in order to be appropriate to the Arabic language and to the Egyptian children. The program was applied using a systematic approach of providing cues to help accelerate the child's learning of the prosodic skills targeted in the program. Cues are adapted from the Dynamic Temporal and Tactile Cueing (DTTC) for Speech Motor Learning hierarchy. It aims at improving motor planning, and programming speech processing as speech and language acquisition progresses.
The program is divided into two sections according to the age into preschool section and school age section.
A pilot study was conducted on 8 cases with hearing impairment attending the phoniatrics unit to check the suitability of the rehabilitation program and modify the needed items.
All subjects met the specified inclusion and exclusion criteria and were assessed by the specified protocol of assessment to evaluate prosodic skills, language skills and cognitive abilities before and after intervention.
Data were analyzed using IBM SPSS software package version 20.0. (Armonk, NY: IBM Corp). Qualitative data were described using number and percent. Chi square test was used for comparison of qualitative variables in two groups, Fisher exact test was used to compare qualitative variables when 50% of cell value was less than 5. McNemar test was used to compare nominal variables before and after intervention. The Kolmogorov-Smirnov test was used to verify the normality of distribution. Quantitative data were described using mean, standard deviation and IQR. Test of significance used included different tests. t test to compare between different means. Mann Whitney U test to compare non normally distributed quantitative variables in two different groups. Paired t test for comparison of normally distributed variables in matched pairs. Wilcoxon signed rank test for pre-post comparison in non-normally distributed quantitative variables. Kappa coefficient was used to assess level of agreement between two raters. Significance of the obtained results was judged at the 5% level.
- Conditions
- Hearing Impaired Children
- Being tested
- Prosody treatment program, Traditional auditory and language rehabilitation
- Keywords
- Hearing impairment, Prosody, Speech rehabilitation, Cochlear implant
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prosody treatment programBehavioural
The "prosody treatment program" is an evidence-based practice targeting receptive and expressive prosodic skills in addition to speech production, intelligibility, pragmatics and phonology. The program incorporates the principles of validated prosodic rehabilitation strategies such as Dynamic Temporal and Tactile Cueing (DTTC), Melodic Intonation Therapy, Lee Silverman Voice Treatment in addition to expert professional practice.
The program was applied using a systematic approach of providing cues to help accelerate the child's learning of the prosodic skills targeted in the program. The program is divided into two sections according to the age into preschool section and school age section.
Traditional auditory and language rehabilitationBehavioural
Auditory rehabilitation therapy included activities targeting auditory skills: sound detection, discrimination, identification and auditory comprehension. Language rehabilitation targeted improving semantics, syntax, pragmatics and phonology.
| Study group | Role | What they receive |
|---|---|---|
| group IA | Experimental | Preschool cases group who received the proposed "prosody treatment program" in addition to the traditional auditory and language rehabilitation therapy. Receives: Behavioral: Prosody treatment program; Behavioral: Traditional auditory and language rehabilitation |
| group IB | Active comparator | preschool control group who received the traditional auditory and language rehabilitation therapy without the prosody rehabilitation program. This was considered the preschool age control group. Receives: Behavioral: Traditional auditory and language rehabilitation |
| group IIA | Experimental | School age cases group who received the proposed "prosody treatment program" in addition to the traditional auditory and language rehabilitation therapy. Receives: Behavioral: Prosody treatment program; Behavioral: Traditional auditory and language rehabilitation |
| group IIB | Active comparator | School age control group who received the traditional auditory and language rehabilitation therapy without the prosody rehabilitation program. This was considered the school age control group. Receives: Behavioral: Traditional auditory and language rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in prosodic skill assessment protocol subjective measures
a quantitative test that evaluates ten prosodic skills, each skill is given a subjective score from 0 to 4 (4 is the best score) with a total score of 40.
Measured: baseline and 3 months
change in prosodic skill assessment protocol mean frequency measures
a quantitative tool that evaluates mean frequency value of recorded utterances in hertz
Measured: baseline and 3 months
change in prosodic skill assessment protocol mean duration measures
a quantitative tool that evaluates mean duration of recorded utterances in msec
Measured: baseline and 3 months
change in prosodic skill assessment protocol mean energy measures
a quantitative tool that evaluates mean energy of recorded utterances in dB
Measured: baseline and 3 months
Change in Arabic prosodic assessment tool subjective ratings
a qualitative tool that rates prosodic skills of recorded utterances as either (A) Appropriate or (I) Inappropriate
Measured: baseline and 3 months
Change in Arabic prosodic assessment tool frequency measures
a quantitative tool that evaluates frequency values of recorded utterances in hertz
Measured: baseline and 3 months
Change in Arabic prosodic assessment tool duration measures
a quantitative tool that evaluates duration of recorded utterances in msec
Measured: baseline and 3 months
Change in Arabic prosodic assessment tool energy measures
a quantitative tool that evaluates energy of recorded utterances in dB
Measured: baseline and 3 months
Secondary outcomes (2)
change in Arabic language test scores
a quantitative too that evaluates language skills, raw scores are converted into language age equivalent scores
Measured: baseline and 3 months
change in values of Stanford Binet scale
a quantitative tool that evaluates intelligence quotient
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start19 Feb 2019
- Primary completion16 Feb 2020
- Study completion16 Feb 2020
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 Hearing Impaired ChildrenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a comparative intervention study comparing the effect of prosodic rehabilitation in addition to the traditional language and auditory training on prosodic skills of hearing impaired children in comparison to traditional language and auditory rehabilitation alone.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Magdy Ibrahim
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Sponsor-investigator, Sara Magdy Ibrahim, Alexandria University
- Investigators
- Ossama A Sobhy, PhD, Principal investigator, Alexandria UniversityRania M Abdou, PhD, Study chair, Alexandria UniversityNesrine H Hammouda, PhD, Study director, Alexandria UniversitySara M Ibrahim, Master's, Study director, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691830
- Sponsor's protocol ID
- 0105832
- Status last verified
- Dec 2020
- First submitted
- 28 Dec 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sobhy OA, Abdou RM, Ibrahim SM, Hamouda NH. Effects of Prosody Rehabilitation on Acoustic Analysis of Prosodic Features in Hearing-Impaired Children: A Randomized Controlled Trial. Folia Phoniatr Logop. 2022;74(1):29-45. doi: 10.1159/000516979. Epub 2021 Jul 21.
PubMed 34289481
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of a Rehabilitation Program for Prosody and Its Application on Egyptian Hearing Impaired Children
- ClinicalTrials.gov ID
- NCT04691830
- Acronym / sponsor ID
- 0105832
- Conditions
- Hearing Impaired Children
- Keywords
- Hearing impairment, Prosody, Speech rehabilitation, Cochlear implant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sara Magdy IbrahimUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 16 Feb 2020 (actual)
- Study completion
- 16 Feb 2020 (actual)
- First posted
- 31 Dec 2020 (actual)
- 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.
Prosody is the melody and rhythm of speech, it is used to refer to the supra segmental aspects of speech including pitch, loudness and duration. Variations in these features achieve different prosodic functions and are perceived by the listener as meaningful changes. The role of prosody in language acquisition and effective communication is documented in research. Nevertheless, prosodic intervention in children with hearing impairment received less attention compared to other speech and language areas.
The aim of this study is to adapt the "prosody treatment program", an evidence based rehabilitation program, and to detect the efficacy of its activities in improving the prosodic skills of Egyptian hearing impaired children.
The "prosody treatment program" is an evidence-based practice targeting receptive and expressive prosodic skills in addition to speech production, intelligibility, pragmatics and phonology. The program is applied using a systematic approach of providing cues following the principles adapted from dynamic temporal and tactile cueing (DTTC) for speech motor learning to help accelerate the child's learning of the prosodic skills targeted in this program. The program was translated to Arabic and adapted to be suitable for the Egyptian children.
Detailed description
Prosody has an important role in several areas of communicative functions including : grammatical, pragmatic, affective and/or indexical functions. Prosodic abnormalities extend across a wide range of communication disorders. Intact functioning auditory system has a fundamental role in language acquisition and development. Children receive the speech of others as a source of linguistic input which is considered their target and they gradually modify their productions using their own auditory feedback to reach the target utterance.
Hearing impairment early in life deprives the child of the source of their linguistic input affecting various aspects of speech and language development. Speech production of the hearing impaired is characterized by various segmental and suprasegmental errors.
Case studies show that interventions targeting prosody can modify prosody in young children with speech and language impairments. Multiple problems of prosody , language, speech and voice are found in individuals with prosodic impairments ,therefore it is challenging to develop treatment protocols addressing prosody .There are only few published interventions targeting prosody .
Due to lack of well structured comprehensive Arabic programs targeting prosody , this work was dedicated towards adaptation of "prosody treatment program" a remediation program targeting receptive and expressive prosodic skills and its application on hearing impaired children .The proposed program targets two levels: preschool and school aged children.
The aim of this work was to adapt the "prosody treatment program" program and apply its activities in cases of hearing impairment to detect its efficacy in improvement of prosodic skills in Egyptian hearing impaired children fitted with hearing aids or cochlear implant devices.
This study was conducted on 55 children with hearing impairment attending the Unit of Phoniatrics , in the outpatient clinic of Alexandria Main University hospital. Sample size was calculated using two proportions power analysis in NCSS and PASS program a minimum sample size required to detect the efficacy of the "prosody treatment program" in improvement of prosodic skills of Egyptian hearing impaired children and to detect a difference of 0.5 that achieve 80% power with a target significance level at 5%.
The proposed program is based on " prosody treatment program", a program targeting receptive and expressive prosodic skills. It includes activities targeting loudness , word stress ,syllable stress ,pitch ,question inflections ,emotions ,sarcasm ,rhythm ,chunking, and speaking rate . The program was adapted in order to be appropriate to the Arabic language and to the Egyptian children. The program was applied using a systematic approach of providing cues to help accelerate the child's learning of the prosodic skills targeted in the program. Cues are adapted from the Dynamic Temporal and Tactile Cueing (DTTC) for Speech Motor Learning hierarchy. It aims at improving motor planning, and programming speech processing as speech and language acquisition progresses.
The program is divided into two sections according to the age into preschool section and school age section.
A pilot study was conducted on 8 cases with hearing impairment attending the phoniatrics unit to check the suitability of the rehabilitation program and modify the needed items.
All subjects met the specified inclusion and exclusion criteria and were assessed by the specified protocol of assessment to evaluate prosodic skills, language skills and cognitive abilities before and after intervention.
Data were analyzed using IBM SPSS software package version 20.0. (Armonk, NY: IBM Corp). Qualitative data were described using number and percent. Chi square test was used for comparison of qualitative variables in two groups, Fisher exact test was used to compare qualitative variables when 50% of cell value was less than 5. McNemar test was used to compare nominal variables before and after intervention. The Kolmogorov-Smirnov test was used to verify the normality of distribution. Quantitative data were described using mean, standard deviation and IQR. Test of significance used included different tests. t test to compare between different means. Mann Whitney U test to compare non normally distributed quantitative variables in two different groups. Paired t test for comparison of normally distributed variables in matched pairs. Wilcoxon signed rank test for pre-post comparison in non-normally distributed quantitative variables. Kappa coefficient was used to assess level of agreement between two raters. Significance of the obtained results was judged at the 5% level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- a comparative intervention study comparing the effect of prosodic rehabilitation in addition to the traditional language and auditory training on prosodic skills of hearing impaired children in comparison to traditional language and auditory rehabilitation alone.
| Arm | Type | Receives |
|---|---|---|
| group IA | Experimental | Behavioral: Prosody treatment program, Behavioral: Traditional auditory and language rehabilitationPreschool cases group who received the proposed "prosody treatment program" in addition to the traditional auditory and language rehabilitation therapy. |
| group IB | Active comparator | Behavioral: Traditional auditory and language rehabilitationpreschool control group who received the traditional auditory and language rehabilitation therapy without the prosody rehabilitation program. This was considered the preschool age control group. |
| group IIA | Experimental | Behavioral: Prosody treatment program, Behavioral: Traditional auditory and language rehabilitationSchool age cases group who received the proposed "prosody treatment program" in addition to the traditional auditory and language rehabilitation therapy. |
| group IIB | Active comparator | Behavioral: Traditional auditory and language rehabilitationSchool age control group who received the traditional auditory and language rehabilitation therapy without the prosody rehabilitation program. This was considered the school age control group. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Hearing impaired children of both sexes, in the preschool age (from 3 to 6 years), and school age (6 to 18 years).
- Children using auditory verbal communication.
- Children with moderately severe or severe up to profound sensorineural hearing loss in unaided conditions, fitted with hearing aids or cochlear implant devices with good benefit (aided hearing threshold less than 40 dB across all frequencies).
Key exclusion criteria (5 listed)
- Children with intellectual disability.
- Children with brain damage.
- Children with additional sensory deprivation (impaired vision).
- Psychiatric problems (example; ASD).
- Motor speech disorders (example: apraxia, dysarthria).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prosody treatment programThe "prosody treatment program" is an evidence-based practice targeting receptive and expressive prosodic skills in addition to speech production, intelligibility, pragmatics and phonology. The program incorporates the principles of validated prosodic rehabilitation strategies such as Dynamic Temporal and Tactile Cueing (DTTC), Melodic Intonation Therapy, Lee Silverman Voice Treatment in addition to expert professional practice. The program was applied using a systematic approach of providing cues to help accelerate the child's learning of the prosodic skills targeted in the program. The program is divided into two sections according to the age into preschool section and school age section. | Behavioural | group IA, group IIA |
| Traditional auditory and language rehabilitationAuditory rehabilitation therapy included activities targeting auditory skills: sound detection, discrimination, identification and auditory comprehension. Language rehabilitation targeted improving semantics, syntax, pragmatics and phonology. | Behavioural | group IA, group IB, group IIA, group IIB |
Primary outcome
change in prosodic skill assessment protocol subjective measures
Time frame: baseline and 3 months
a quantitative test that evaluates ten prosodic skills, each skill is given a subjective score from 0 to 4 (4 is the best score) with a total score of 40.
change in prosodic skill assessment protocol mean frequency measures
Time frame: baseline and 3 months
a quantitative tool that evaluates mean frequency value of recorded utterances in hertz
change in prosodic skill assessment protocol mean duration measures
Time frame: baseline and 3 months
a quantitative tool that evaluates mean duration of recorded utterances in msec
change in prosodic skill assessment protocol mean energy measures
Time frame: baseline and 3 months
a quantitative tool that evaluates mean energy of recorded utterances in dB
Change in Arabic prosodic assessment tool subjective ratings
Time frame: baseline and 3 months
a qualitative tool that rates prosodic skills of recorded utterances as either (A) Appropriate or (I) Inappropriate
Change in Arabic prosodic assessment tool frequency measures
Time frame: baseline and 3 months
a quantitative tool that evaluates frequency values of recorded utterances in hertz
Change in Arabic prosodic assessment tool duration measures
Time frame: baseline and 3 months
a quantitative tool that evaluates duration of recorded utterances in msec
Change in Arabic prosodic assessment tool energy measures
Time frame: baseline and 3 months
a quantitative tool that evaluates energy of recorded utterances in dB
2 secondary outcomes
change in Arabic language test scores
Time frame: baseline and 3 months
change in values of Stanford Binet scale
Time frame: baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Derived from this study: PubMed 34289481Sobhy OA, Abdou RM, Ibrahim SM, Hamouda NH. Effects of Prosody Rehabilitation on Acoustic Analysis of Prosodic Features in Hearing-Impaired Children: A Randomized Controlled Trial. Folia Phoniatr Logop. 2022;74(1):29-45. doi: 10.1159/000516979. Epub 2021 Jul 21.
- Individual participant dataSharing planned: No
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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.
Ossama A Sobhy, PhD principal investigator
Alexandria University
Rania M Abdou, PhD study chair
Alexandria University
Nesrine H Hammouda, PhD study director
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prosody treatment program and Traditional auditory and language rehabilitation in people with Hearing Impaired Children, run by Sara Magdy Ibrahim at 1 site in Egypt.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 31 Dec 2020. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in prosodic skill assessment protocol subjective measures (time frame: baseline and 3 months). The study lists 8 primary outcomes in all. 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 NCT04691830, 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 31 Dec 2020.