1.
ClinicalTrials.gov; 18/05/2022; TrialID: NCT05389124
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05389124
ABSTRACT
Condition:
Gingivitis;Oral DiseaseIntervention:
Behavioral: Partial abstinence from oral hygienePrimary outcome:
Metagenomic sequenceCriteria:
Inclusion Criteria:
- have read, understood and signed an informed consent form
- be adults of age 18 years or over
- have a minimum of 20 natural teeth (excluding third molars)
- be willing and able to comply with study procedures
- be a non-smoker and non-user of e-cigarettes or other oral intake nicotine replacement
therapy (or have quit smoking/e-cigarettes/oral intake nicotine replacement therapy at
least 2 years previously)
- healthy participants: good oral (no sites with interproximal attachment loss, GI = 2.0
in = 10% sites, %BOP scores = 10%) and good general health.
- Covid-19 negative by LFT and fully vaccinated
Exclusion Criteria:
- infectious or systemic diseases that may be unduly affected by participation in this
study
- extensive crown or bridge work and/or rampant decay at the discretion of the examiner
- wear removable partial dentures, a fixed/removable orthodontic appliance
- diabetes
- history of xerostomia, salivary gland disease, head and neck radiotherapy, Sjögren's
syndrome, mucocutaneous disorders of the oral cavity, vesicobullous disorders of the
oral cavity
- smoking or use of e-cigarettes within the last 2 years
- current use of prescription or over-the-counter medications that could affect salivary
flow, at the discretion of the examiner
- lack of capacity to be able to consent to the research project and/or inability to
follow study instructions
- pregnant by medical history or nursing
- currently undergoing or requiring extensive dental, orthodontic or implant treatment,
or treatment for peri-implantitis
- treatment with antibiotics for any medical or dental condition within 4 weeks prior to
enrolment
- scale and polish within 4 weeks prior to enrolment
- long term use of antibiotics or non-steroidal anti-inflammatory drugs (prophylactic
low dose aspirin is permitted though)
- evidence of drug induced gingival overgrowth
- participation in a dental research study within the previous 20 days.
- Unilever personnel and personnel in the University department performing the study
2.
ISRCTN; 12/05/2022; TrialID: ISRCTN18015802
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN18015802
ABSTRACT
Condition:
Post-COVID fatigueInfections and Infestations
Intervention:
In this study, participants will be required to self-administer electrical stimulation to the external ear to activate nerves running beneath the surface of the skin. A FlexiStim (TensCare, Epsom, UK) transcutaneous electrical nerve stimulation (TENS) device will be used for this purpose. These devices are commercially available over the counter (OTC), or online without prescription, and having been specifically developed for safe use without training and with only minimal written instructions participants should find these TENS devices straightforward to use.
The research assistant (RA; or research team member) will set up the stimulation parameters for the TENS device and train the participant to use the device at the end of their visit to the laboratory, after completing laboratory assessments. The RA will first explain to each participant that, ‘the aim of the study is to test the effects on fatigue of stimulating different parts of the ear lobe at different levels of stimulation’. The RA will then set stimulus parameters during the TENS demonstration by determining sensory threshold and pain/discomfort threshold for tragus, pinna and earlobe stimulation and instructing the participant to set the TENS at a specified current setting whenever it is used.
To activate the auricular branch of the vagus nerve (taVNS) a clip electrode connected to the TENS system will be attached to the left tragus. Fabric sleeves, cut to the correct length to cover the two prongs of the ear clip electrode, ensure that the electrode gel (Spectra 360 Electrode Gel, Parker Laboratories Inc, NJ, USA) applied in between the ear clip electrode, or that the saline used to moisten the sleeves, makes a good electrical contact with skin of the trag
Primary outcome:
Fatigue assessed using a visual analogue scale (VAS) at Week 1, Week 2, Week 4, Week 8, Week 12, Week 16Criteria:
Inclusion criteria:1. Members of the public (adults) who have a verifiable positive COVID diagnosis (COVID+) but who did not require hospitalisation and who are at least 4 weeks after diagnosis, will be recruited via the trial website (http://covidfatigue.org.uk/), social media and radio advertisements. They will be screened for symptoms of fatigue using an electronic implementation of the Fatigue Impact Scale
2. Aged =18 and <65 years
3. Able to provide written informed consent in English
4. No previous diagnosis of neurological or psychiatric disorder
5. No cardiac disease (e.g., cardiomyopathy, myocardial infarction, arrhythmia, prolonged QT interval, etc)
6. No implanted device (e.g., pacemaker)
7. Not pregnant
8. Fluent in English
Exclusion criteria:
1. Previous diagnosis of neurological or psychiatric disorder
2. Cardiac disease (e.g., cardiomyopathy, myocardial infarction, arrhythmia, prolonged QT interval, etc)
3. Implanted device (e.g., pacemaker)
4. Pregnant
5. Not fluent in English
3.
ISRCTN; 22/04/2021; TrialID: ISRCTN48563324
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN48563324
ABSTRACT
Condition:
Bathing adaptations in the homes of older adultsNot Applicable
Intervention:
Current interventions as of 13/07/2023:Participants will be randomly allocated 1:1 to the usual care or intervention group. We will use “pairwise” randomisation. The randomisation will be stratified by ability to complete the SF-36; for those participants who can self-complete the SF-36, it will be further stratified by site and property tenure, and for those who can not, it will be stratified by site only. Additional flexibility of the strata will be considered in cases where finding a pair is problematic. The randomisation sequence will be generated by a statistician at York Trials Unit.
Study groups:
Control: Usual waiting list group. People in this group will remain on the usual waiting list and be allocated to a project officer surveyor to begin the adaptations process when they reach the top of the waiting list and/or by the usual processes and timescales within the local authority. The waiting list at our sites before the COVID-19 pandemic was between 4 and 9 months, but this can vary.
Intervention: Accelerated list group. People in this group will be allocated to a project officer/surveyor to begin the adaptations process and/or will have their adaptations process expedited by active management of the process and rapid or fast-tracked contracting.
Baseline consultation:
Local authority staff will contact people who have been referred for an accessible shower to let them know they have been added to a waiting list for this. If the person fulfils the eligibility criteria the administrator will also give a brief overview of the study and ask permission for a research assistant to make contact with them about the study and to send further information. If a participant requires consultee support either a personal or nominated consultee will attempt to be identif
Primary outcome:
Current primary outcome measure as of 13/07/2023:Physical Component Summary score (PCS) of the SF-36 measured in:
1. Both groups at baseline
2. Four weeks post-adaptation in the intervention group
3. Four weeks post-adaptation in control group
4. 12 weeks post-adaptation in control group
_____
Previous primary outcome measure:
Physical Component Summary score (PCS) of the SF-36 measured in:
1. Both groups at baseline
2. Four weeks post-adaptation in the intervention group
3. Two weeks pre-adaptation in control group
4. Four weeks post-adaptation in control group
5. 12 weeks post-adaptation in control group
Criteria:
Inclusion criteria: Current inclusion criteria as of 13/07/2023:1. People aged 60 years or over
2. People referred for a major adaptation for provision of an accessible (level or easy access) showering facility. This may be by removal of an existing bath or shower cubicle.
3. People living in housing owned by the local authority or living in privately-owned housing (owner-occupied, privately rented, housing association owned) and appear to be eligible for a Disabled Facilities Grant (DFG) and/or assistance from the local authority.
The study will include people who do not speak English and will provide interpreters. The researchers will use the interpreting agency at the site.
_____
Previous inclusion criteria as of 27/07/2021:
1. People aged 65 years or over
2. People referred for a major adaptation for provision of an accessible (level or easy access) showering facility. This may be by removal of an existing bath or shower cubicle.
3. People living in housing owned by the local authority or living in privately-owned housing (owner-occupied, privately rented, housing association owned) and appear to be eligible for a Disabled Facilities Grant (DFG) and/or assistance from the local authority.
The study will include people who do not speak English and will provide interpreters. The researchers will use the interpreting agency at the site.
_____
Previous inclusion criteria:
1. People aged 65 years or over
2. People referred for a major adaptation for provision of an accessible (level or easy access) showering facility. This may be by removal of an existing bath or shower cubicle.
3. People living in housing owned by the local authority or living in privately-owned housing (owner-occupied, privately rented, housing association owned) and appear to be eligible for a Disabled Facilities Grant (DFG)
The study will include people who do not speak English and will provide interpreters. The researchers will use the interpreting agency at the site.
Exclusion criteria: 1. People referred for an accessible showering facility plus one or more other adaptations (e.g. ramps, hoists, lifts) as these adaptations are more complex and will involve extended timescales
2. People referred for a rapid, fast-tracked or urgent priority bathing adaptation
3. People who lack the mental capacity to provide informed consent and we are unable to identify a personal or nominated consultee
4. People who lack the mental capacity to provide informed consent and who are unable to provide any study outcomes with support or where we are unable to identify an “alternative participant” to provide data
4.
ISRCTN; 08/01/2020; TrialID: ISRCTN10974028
Clinical Trial Register
| ICTRP | ID: ictrp-ISRCTN10974028
ABSTRACT
Condition:
Language disorderMental and Behavioural Disorders
Developmental disorder of speech and language, unspecified
Intervention:
Current interventions as of 24/02/2021:The Heather van der Lely Foundation has granted funding to Newcastle and Manchester Universities to conduct a cluster randomised control trial across 24 schools in the North East of England. Schools will be recruited from Newcastle, South Tyneside and Gateshead. If more than the target number are recruited, 24 will be randomly chosen to be part of the trial. This group of 24 will be split into two geographical areas of 12 schools (areas A and B) to facilitate timely
delivery of the interventions by the research team and to complete intervention delivery and data collection within allocated resources.
As a result of changes made due to COVID-19 the number of schools involved in the project for each wave of the study has been reduced. Some schools have left the project meaning there are now 21 schools participating. Some of these 21 schools will work with the project during the first wave (March-Sept 2021), up to 16 schools will work with the project for the second wave (Sept 2021-April 2022). Some will work with the project for both waves. This was determined based on
which schools were able to commit to the project. If a school participates in both waves they will remain in the same arm. The schools have been split into two geographical areas.
Schools were randomized to one of three arms; (Building Early Sentences Therapy (BEST), Derbyshire Language Scheme (DLS) and Continued Classroom Support (CCS)). The randomization was undertaken by the minimization method, attempting to balance across the arms on geographic region (A/B) and the proportion of pupils eligible for Pupil Premium (High/Low). The minimization method attempts to balance these factors across the treatment arms. A median split on the school proportion of pupils el
Primary outcome:
Current primary outcome measure as of 24/02/2021:The outcomes of interest are children’s oral language development and their communicative participation. Children are assessed on all outcome measures at three time-points: baseline, outcome and follow-up. Baseline testing will happen when children are identified at the start of each wave, Outcome testing within 4 weeks of end of intervention, and Follow up testing approximately 8-12 weeks after intervention. Intervention group comparisons will be made on measures at outcome and at follow-up.
Intention to treat and per protocol analyses will be conducted on all outcome measures which vary in their hypothesised distance from the intervention taught material.
1. Near: targeted sentence structures assessed through experimenter designed BEST and DLS assessments including picture description eliciting targeted sentence structures and a ‘toy test’ to assess comprehension of these sentences.
2. Intermediate: New Reynell Developmental Language Scales.
3. Far: FOCUS (Focus on the Outcomes of Communication Under Six); parent and teacher report measure of communicative participation.
Use of near, intermediate and far outcomes allow exploration of differences between interventions with respect to the degree to which learning transfers to broader language skills and communicative participation. Hence we do not make a distinction between primary and secondary outcomes but rather explore the effects on all 3 outcomes. It is possible that different approaches may have differing effects for each outcome.
For intention-to-treat analyses the average outcome score across the three treatment arms on the relevant outcome measure will be used for all missing data. Per-protocol analyses will be conducted on all children with complete outcome data. Qualitative data regarding barriers and enablers to intervention delivery (reflective field notes) will be triangulated with a comparison between intention-to-treat and per-protocol outcomes to inform successful implementation of effective interventions into practice.
Moderator analyses will be completed to identify whether differential effects across language interventions exist depending upon the children’s language profiles (severity, receptive-expressive language difficulties and/or scores on morpho-phonological processing).
A moderator analysis will be completed using Vineland 3 scores to determine whether differential effects exist depending on non-verbal ability.
Finally, a latent variable outcome analysis will be conducted using the three direct assessments of oral language using multilevel structural equation modelling (SEM) to account for the cluster randomisation. The outcome will be a latent language variable created from the New Reynell Developmental Language Scales, the BEST and DLS language assessments. The rationale for this approach is to evaluate to what degree the interventions may affect a unitary underlying language factor. The effects of the intervention will be measured by an appropriate effect size such as standardized differences in means comparing the two treatment arms.
_____
Previous primary outcome measure:
The outcomes of interest are children’s oral language development and their communicative participation. Children are assessed on all outcome measures at three time-points: baseline, outcome and follow-up. Baseline testing will happen when children are identified at the start of each wave, Outcome testing within 4 weeks of end of intervention, and Follow up testing approximately 8-12 weeks after intervention. Intervention group comparisons will be made on measures at outcome and at follow-up.
Intention to treat and per protocol analyses will be conducted on all outcome measures which vary in their hypothesised distance from the intervention taught material.
1. Near: targeted sentence structures assessed through experimenter designed BEST and DLS assessments including picture description eliciting targeted sentence structures and a ‘toy test’ to assess comprehension of these sentences.
2. Intermediate: New Reynell Developmental Language Scales.
3. Far: FOCUS (Focus on the Outcomes of Communication Under Six); parent and teacher report measure of communicative participation.
Use of near, intermediate and far outcomes allow exploration of differences between interventions with respect to the degree to which learning transfers to broader language skills and communicative participation. Hence we do not make a distinction between primary and secondary outcomes but rather explore the effects on all 3 outcomes. It is possible that different approaches may have differing effects for each outcome.
For intention-to-treat analyses the average outcome score across the three treatment arms on the relevant outcome measure will be used for all missing data. Per-protocol analyses will be conducted on all children with complete outcome data. Qualitative data regarding barriers and enablers to intervention delivery (reflective field notes) will be triangulated with a comparison between intention-to-treat and per-protocol outcomes to inform successful implementation of effective interventions into practice.
Moderator analyses will be completed to identify whether differential effects across language interventions exist depending upon the children’s language profiles (severity, receptive-expressive language difficulties and/or scores on morpho-phonological processing).
Finally, a latent variable outcome analysis will be conducted using the three direct assessments of oral language using multilevel structural equation modelling (SEM) to account for the cluster-randomisation. The outcome will be a latent language variable created from the New Reynell Developmental Language Scales, the BEST and DLS language assessments. The rationale for this approach is to evaluate to what degree the interventions may affect a unitary underlying language factor. The effects of the intervention will be measured by an appropriate effect size such as standardized differences in means comparing the three treatment arms.
Criteria:
Inclusion criteria: 1. Aged 3.5 - 4.5 years2. Monolingual speaker of English/English as main language
3. Scoring at or below the 16th centile on a standardised play-based language assessment
4. With the ability to participate in a small group learning context
Exclusion criteria: 1. Sensorineural hearing impairment
2. Severe visual impairment
3. Diagnosed learning disability