Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT05766020
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-09
First Post:
2023-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Training Listening Skills With the Inclusion of Cognitive Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-07', 'studyFirstSubmitDate': '2023-02-15', 'studyFirstSubmitQcDate': '2023-03-09', 'lastUpdatePostDateStruct': {'date': '2024-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Speech in noise intelligibility', 'timeFrame': '0 weeks', 'description': 'LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.'}, {'measure': 'Speech in noise intelligibility', 'timeFrame': '4 weeks', 'description': 'LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.'}, {'measure': 'Speech in noise intelligibility', 'timeFrame': '8 weeks', 'description': 'LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.'}, {'measure': 'Speech in noise intelligibility', 'timeFrame': '12 weeks', 'description': 'LIST (Leuven intelligibility sentences test) sentences presented in speech-weighted noise. Participants are required to repeat sentences in noise. The Leuven Intelligibility Sentences Test (LIST) was specifically designed for speech perception in noise assessment in CI users. The test has high test-retest reliability and a steep slope making it very sensitive to small improvements in performance. An improvement of 2dB results in a clinically relevant improvement in speech discrimination in noise. Therefore, the primary endpoint to validate the active training will be an improvement of 2dB on speech perception in noise.'}, {'measure': 'phoneme identification in noise', 'timeFrame': '0 weeks', 'description': 'The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.'}, {'measure': 'phoneme identification in noise', 'timeFrame': '4 weeks', 'description': 'The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.'}, {'measure': 'phoneme identification in noise', 'timeFrame': '8 weeks', 'description': 'The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.'}, {'measure': 'phoneme identification in noise', 'timeFrame': '12 weeks', 'description': 'The consonant identification task in noise consisted of 12 Dutch/Flemish vowels presented in an /a/ context. Stimuli were produced by a female speaker. In order not to obtain 100% at the start, stimuli were presented in speech-weighted noise.'}], 'secondaryOutcomes': [{'measure': 'The temporal modulation Transfer function', 'timeFrame': '0 weeks', 'description': 'With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.'}, {'measure': 'The temporal modulation Transfer function', 'timeFrame': '4 weeks', 'description': 'With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.'}, {'measure': 'The temporal modulation Transfer function', 'timeFrame': '8 weeks', 'description': 'With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.'}, {'measure': 'The temporal modulation Transfer function', 'timeFrame': '12 weeks', 'description': 'With this task, we measure the modulation threshold that listeners need to distinguish between unmodulated and modulated noise, which is related to speech understanding.'}, {'measure': 'Dual-task listening postural control', 'timeFrame': '0 weeks', 'description': 'This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.'}, {'measure': 'Dual-task listening postural control', 'timeFrame': '4 weeks', 'description': 'This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.'}, {'measure': 'Dual-task listening postural control', 'timeFrame': '8 weeks', 'description': 'This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.'}, {'measure': 'Dual-task listening postural control', 'timeFrame': '12 weeks', 'description': 'This task aims at identifying the ability to perform two tasks simultaneously. Participants will perform a listening-posture dual-task, where they have to maintain their balance while listening and repeating heard sentences.'}, {'measure': 'Stroop task', 'timeFrame': '0 weeks', 'description': "The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself."}, {'measure': 'Stroop task', 'timeFrame': '4 weeks', 'description': "The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself."}, {'measure': 'Stroop task', 'timeFrame': '8 weeks', 'description': "The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself."}, {'measure': 'Stroop task', 'timeFrame': '12 weeks', 'description': "The Stroop task assesses inhibitory control by requiring participants to identify the color in which a symbol or word is presented while ignoring the word's meaning. Participants were asked to respond to the color of the word while ignoring the written word, which is a color itself."}, {'measure': 'EAS (Effort Assessment Scale)', 'timeFrame': '0 weeks', 'description': 'EAS is a validated scale to measure listening effort. The EAS consists of 6 items that are scored by the client on a 10-point scale, no effort to lots of effort. The EAS questions were translated to Dutch for this study.'}, {'measure': 'EAS (Effort Assessment Scale)', 'timeFrame': '4 weeks', 'description': 'EAS is a validated scale to measure listening effort. The EAS consists of 6 items that are scored by the client on a 10-point scale, no effort to lots of effort. The EAS questions were translated to Dutch for this study.'}, {'measure': 'SSQ12 (Speech, Spatial and Qualities of Hearing Scale)', 'timeFrame': '0 weeks', 'description': 'The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.'}, {'measure': 'SSQ12 (Speech, Spatial and Qualities of Hearing Scale)', 'timeFrame': '4 weeks', 'description': 'The SSQ12 is a short version of the validated Speech, Spatial and Qualities of Hearing Scale. This short form was developed for use in clinical research and rehabilitation settings. Participants score each questions on a ruler (visual analogue scale) from 0 to 10. Questions were translated to Dutch.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hearing Disability']}, 'referencesModule': {'references': [{'pmid': '10229511', 'type': 'BACKGROUND', 'citation': 'van Wieringen A, Wouters J. Natural vowel and consonant recognition by Laura cochlear implantees. Ear Hear. 1999 Apr;20(2):89-103. doi: 10.1097/00003446-199904000-00001.'}, {'pmid': '18569107', 'type': 'BACKGROUND', 'citation': 'van Wieringen A, Wouters J. LIST and LINT: sentences and numbers for quantifying speech understanding in severely impaired listeners for Flanders and the Netherlands. Int J Audiol. 2008 Jun;47(6):348-55. doi: 10.1080/14992020801895144.'}, {'pmid': '6615338', 'type': 'BACKGROUND', 'citation': 'Noble W. Hearing, hearing impairment, and the audible world: a theoretical essay. Audiology. 1983;22(4):325-38. doi: 10.3109/00206098309072793.'}, {'pmid': '27541332', 'type': 'BACKGROUND', 'citation': 'Alhanbali S, Dawes P, Lloyd S, Munro KJ. Self-Reported Listening-Related Effort and Fatigue in Hearing-Impaired Adults. Ear Hear. 2017 Jan/Feb;38(1):e39-e48. doi: 10.1097/AUD.0000000000000361.'}, {'pmid': '39924678', 'type': 'DERIVED', 'citation': 'Van Wilderode M, Van Humbeeck N, Krampe RT, van Wieringen A. Enhancing Speech Perception in Noise Through Home-Based Competing Talker Training. Ear Hear. 2025 Jul-Aug 01;46(4):856-870. doi: 10.1097/AUD.0000000000001631. Epub 2025 Feb 10.'}]}, 'descriptionModule': {'briefSummary': 'Participating in spoken conversation constitutes a multitasking situation with concurrent demands on sensorimotor (auditory, postural) and cognitive functioning (memory, updating, task switching and inhibition). As aging affects multisensory integration and cognitive control, these higher-order processes are likely to put accumulating constraints on listening as adults grow older. By training listening skills (not solely auditory skills), the investigators aim at improving overall communication and quality of life. Moreover, the investigators aim at freeing up cognitive resources in the listen task: the better one gets at a certain domain specific task, the less one needs to draw from other resources and, the more resources are free for another concurrent task. The interdisciplinary approach will inform us about ideal audiological rehabilitation or intervention approaches. Pre-posttests comprise behavioral measures to evaluate listening skills and transfer towards non-trained measures. The training is tablet-based and can be performed at home.', 'detailedDescription': 'Goals of the study:\n\n* Investigate transfer of listening skills to non-trained listening.\n* To develop evidence-based guidelines for clinical audiological rehabilitation.\n* Investigate if the inclusion of cognitive control frees up cognitive resources to use for another concurrent task.\n* Inform about retention following listening training\n\nAll participants will be assessed 4 times, with a 4-week interval in between. Participants in the first arm will perform the training during the first two weeks. 4 weeks after training ended and 8 weeks after training ended, retention of training gains will be assessed. Participants in the second arm will perform the delayed training. This is to control for procedural learning effects. After 4 weeks they will start training for 4 weeks. After training retention of training gains will be assessed after 4 weeks. The third arm will start with active control training (listening to stories) for 4 weeks, followed by training for 4 weeks. After these 8 weeks, retention was measured 4 weeks later. Participants are randomly allocated to a group. The efficacy of training will be determined with a within-subject design (i.e. baseline session outcomes will be compared to the final session outcomes of the randomized control trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Clients who experience listening and communication difficulties.\n* Clients must not undergo any audiological rehabilitation (auditory training/hearing aid fitting) during the study.\n* Able to operate the training programme as an app on a tablet (e.g. clients have sufficient eyesight to see the exercises; clients must be able to operate the programme).\n* At least 18 years old.\n* Dutch-speaking, as all training material and counselling questions will be presented in Dutch.\n\nExclusion Criteria (all groups):\n\n* Severely visually impaired\n* Motorically impaired\n* Cognitively impaired'}, 'identificationModule': {'nctId': 'NCT05766020', 'acronym': 'TRAILS', 'briefTitle': 'Training Listening Skills With the Inclusion of Cognitive Control', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Training Listening Skills With the Inclusion of Cognitive Control', 'orgStudyIdInfo': {'id': 'S63310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Immediate training group', 'description': 'Participants in this group will train immediately for 4 weeks. Afterwards, they will not train for the 8 remaining weeks.', 'interventionNames': ['Behavioral: Listen training']}, {'type': 'EXPERIMENTAL', 'label': 'Delayed Training Group', 'description': 'Participants in this group will receive delayed training after 4 weeks of no training.', 'interventionNames': ['Behavioral: Listen training']}, {'type': 'EXPERIMENTAL', 'label': 'Active control group', 'description': 'Participants in this group will perform an active control for 4 weeks, followed by 4 weeks of training.', 'interventionNames': ['Behavioral: Listen training']}], 'interventions': [{'name': 'Listen training', 'type': 'BEHAVIORAL', 'description': 'Auditory skills with the inclusion of cognitive control.', 'armGroupLabels': ['Active control group', 'Delayed Training Group', 'Immediate training group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3001', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'KU Leuven, Experimental ORL, Dept Neurosciences', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Astrid van Wieringen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Dr.', 'investigatorFullName': 'Astrid Van Wieringen, PhD', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}