TinnitusNCT03386123
A Comparison of CBTi and Usual Treatment for Tinnitus Related Insomnia
A study testing Cognitive Behaviour Therapy for Insomnia, Standard Audiological Care and Sleep Support Group in people with Tinnitus and Insomnia, run by University College London Hospitals at 1 site in United Kingdom.
Trial summary
There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain. This study will investigate the effectiveness of CBTi as a treatment for tinnitus related insomnia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Cognitive Behaviour Therapy for Insomnia, Standard Audiological Care and Sleep Support Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2017to 31 Dec 2019
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least moderately distressing tinnitus (above a set minimum score on the Mini TQ) for at least six months and problematic insomnia (above a set minimum score on the Insomnia Severity Index (ISI) and for tinnitus related insomnia to be identified in clinical interview) as result of tinnitus, for at least three months.
- Patient wishes to work on improving sleep.
- Sufficient understanding of English and sufficient hearing ability to take part in for group discussions and to complete questionnaires.
- Patient has had tinnitus assessed by a doctor and an audiological specialist.
- Willing and able to provide written consent. Able to regularly attend clinic in London, United Kingdom.
Who cannot join
- • Organic sleep disorders present (e.g. Obstructive Sleep Apnoea, delayed phase sleep, etc.) assessed with a subscale of the hospital sleep unit's sleep disorder and snoring proforma.
- Currently pregnant, planning pregnancy or breastfeeding.
- Alcohol or drug dependent.
- Currently suffering with severe mental illness (psychosis, severe anxiety or mood disorder).
- Reports active risk to themselves or others. Still undergoing medical investigations into sleep and / or tinnitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Cognitive Behaviour Therapy for Insomnia (CBTi) and Usual Audiological Rehabilitation in the Management of Tinnitus Related Insomnia
There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain.
This study will investigate the effectiveness of CBTi as a treatment for tinnitus related insomnia. Tinnitus patients reporting clinically significant insomnia will be offered sleep-specific treatment. Six sessions of CBTi will be offered to one group of patients and 2 sessions standard audiological care (psycho-education and sleep hygiene) will be offered to another group. Both groups will be offered sound enrichment at night. In order to take account of the possible effects of clinical contact a third group will be offered 6 sessions of support without a focused tinnitus or sleep intervention. Accepted measures of sleep disturbance will be used as well as measures of tinnitus complaint.
All treatment/contact will be provided at the Royal National Throat Nose \& Ear Hospital. Participants will be involved in the study (inc. baseline period {2 weeks}, intervention {8 weeks} and follow-ups {4 and 20 weeks}) for 34 weeks.
- Being tested
- Cognitive Behaviour Therapy for Insomnia, Standard Audiological Care, Sleep Support Group
- Keywords
- Tinnitus, Insomnia, Cognitive Behaviour Therapy
- Medical subject headings
- Tinnitus, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behaviour Therapy for InsomniaBehavioural
Continuous maintenance of sleep diary, cognitive behaviour therapy, including cognitive restructuring, and behavioural change focusing on sleep restriction and safety behaviours.
Standard Audiological CareBehavioural
Maintenance of sleep diary at key times. Psycho-education, provision of bedside sound generator.
Sleep Support GroupBehavioural
Maintenance of sleep diary at key times. Social support focused on tinnitus and sleep problems.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behaviour Therapy for Insomnia (CBTi) | Experimental | A standard CBTi programme for the treatment of primary insomnia, with six, 2 hour, group sessions over eight weeks. There will be minor adaptations for tinnitus, including making specific reference to tinnitus and psycho-education about tinnitus. Every session concludes with provision of a homework task and a sleep diary to complete over the next week. The CBTi course will be supported by providing participants with a CD with some relaxation exercises and a booklet that covers the information given in the session.
CBTi includes: Sleep restriction, stimulus control, Sleep hygiene, Relaxation training, Paradoxical intention, Cognitive therapy: Targeting unhelpful beliefs about sleep and worry, Behavioural experiments: Testing unhelpful beliefs and adjusting sleep related behaviour. Receives: Behavioral: Cognitive Behaviour Therapy for Insomnia |
| Standard Audiological Care (SAC) | Active comparator | A group intervention that fits with reported audiological treatment of people with tinnitus and significant sleep impairment. This involves psycho-education about tinnitus, habituation, sleep and sleep hygiene. Relaxation will be advised and information provided. A bedside sound generator, as used in routine clinical practice will be provided. Information will be based on standard advice given by hearing therapists/audiologists and will not include specific psychological techniques which are not part of SAC. The group will be generally supportive.
SAC tends not to involve repeated meetings; after the initial session, there will be one follow up session 8 weeks later. Follow up will allow for question and answer, and reports on what has been useful. Both sessions will last for 2 hours Receives: Behavioral: Standard Audiological Care |
| Sleep Support Group (SSG) | Placebo comparator | Participants will meet in a group, which will offer equivalent contact with therapists and a supportive group milieu as CBTi. It will focus on the potential benefits of a supportive group and will not include specific advice.
Participants will complete 2-week sleep diaries as baseline and outcome measures at the four time-points, which will be checked within the session to ensure that participants know how to complete them correctly. The SSG will meet in a group for six sessions, over eight weeks, each of 2 two hours duration. Receives: Behavioral: Sleep Support Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI) score
7-item questionnaire, each item rates 0 - 4. Total scores range from 0-28 with higher scores indicating more severity.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in the amount of sleep obtained
Average of all of the following metrics obtained from 2 weeks of sleep diary measure:
Sleep Onset Latency - lower score indicates better sleep; Wake Time After Sleep Onset - lower score indicate better sleep; Number of night time awakenings - lower scores indicate better sleep; Total Sleep Time - higher scores indicate better sleep; Time in Bed - included only so that Sleep Efficiency can be calculated: Sleep Efficiency (Total Sleep Time / Time in Bed x 100) - higher scores indicate better sleep.
Diary measures for sleep quality (0= worst possible to 10=best possible), tinnitus annoyance (0= not at all to 10= extremely), refreshed at waking (0= not at all to 10= very refreshed) and quality of day time functioning (0= very poor to 10= very good).
Measured: A 2-week sleep diary will be kept 2 weeks prior to the first and last treatment sessions and to the 1 and 6 month follow-ups.
Secondary outcomes (12)
Change in Pittsburgh Sleep Quality Index score
10-item questionnaire. Sum of 7 components; global score range 0 - 21; higher scores indicate worse sleep quality.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Dysfunctional Beliefs and Attitudes About Sleep Questionnaire - abbreviated version (DBAS-16) score
16-item questionnaire scored on a 0-10 scale. The average score is calculated from all individual scores and ranges from 0-10; higher scores indicate more dysfunctional / unrealistic beliefs about / sleep.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Tinnitus Catastrophizing Scale score
13-item questionnaire scored on a 0-4 scale. Total sum of scores range from 0 - 52. Higher scores indicate higher levels of catastrophizing.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Mini Tinnitus Questionnaire score
Construct: Tinnitus complaint 12-item questionnaire scored on a 0 - 2 scale. Total sum of scores range 0-24. Higher scores indicate presence of tinnitus. A score of 8 or more indicates the presence of a clinical level of tinnitus-related distress.
Measured: Screening
Change in the Tinnitus Questionnaire score
Construct: Tinnitus complaint 41-item questionnaire scored on a 0 - 2 scale. Total sum of scores ranges from 0-82; higher scores indicate presence of tinnitus. The reliable change criterion is 11.08.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in subjective measure of tinnitus loudness
Visual Analogue Scale from 0mm to 100mm; higher scores indicate greater loudness of tinnitus.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Clinical Outcome in Routine Evaluation - Outcome Measure score
Construct: general psychological distress 34-item questionnaire scored on a 0-4 scale. The average of all the scores is calculated and then multiplied by 10, so the scores can range from 0 to 40; a clinical cut-off score is 10 and clinically significant change is 5.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Patient Health Questionnaire-9 score
Construct: Depression 9-item questionnaire scored on a 0-3 scale; total sum of scores ranges from 0-27 with higher scores indicate greater depression severity.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Generalized Anxiety Disorder Assessment-7 score
7-items questionnaire scored on a 0-3 scale; total sum of scores ranges from total score range: 0-21 with higher score indicating more severe anxiety.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in EuroQOL score
Construct: health status (dimensions: mobility, self-care, performing usual activities, pain or discomfort; anxiety or depression); each state is referred to in terms of a 5 digit code; The answers given to EQ-5D allow 243 unique health states to be identified and can be converted into EQ-5D index and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analogue Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Work and Social Adjustment Scale score
Construct: impaired functioning 5-item questionnaire scored on a 0-8 scale; total sums of scores range from 0-40 with higher scores indicating greater functional impairment.
Measured: At first and last treatment sessions and at 1 and 6 month follow-ups
Satisfaction and feedback
Questionnaire asking individuals to rate the following on a 0 - 10 scale (from not at all to extremely) How useful was treatment? How relevant was treatment? How acceptable was treatment? They are also asked to provide qualitative feedback in the form of comments in response to questions about what changes they have noticed, what aspects of treatment were most and least useful, what they would have liked to be different and any other comments.
Measured: At the end of treatment and at six month follow-up point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start28 Jun 2017
- Primary completion10 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TinnitusStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- British Tinnitus Association, University College, London
- Responsible party
- Principal investigator, Dr Laurence McKenna, University College London Hospitals
- Investigators
- Laurence Laurence, PhD, Principal investigator, University College London Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386123
- Sponsor's protocol ID
- UCLondonH
- Status last verified
- Jun 2019
- First submitted
- 8 Dec 2017
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cramer L, Vogt F, McKenna L, Marks E. How people with tinnitus-related insomnia experience group CBT-for-insomnia (CBTi): a thematic analysis. Int J Audiol. 2024 Mar;63(3):190-198. doi: 10.1080/14992027.2022.2161016. Epub 2023 Jan 16.
PubMed 36645178Marks E, Hallsworth C, McKenna L. Cognitive behavioural therapy for insomnia (CBTi) as a treatment for tinnitus-related insomnia: protocol for a randomised controlled trial. Trials. 2019 Dec 2;20(1):667. doi: 10.1186/s13063-019-3778-5.
PubMed 31791396
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Cognitive Behaviour Therapy for Insomnia (CBTi) and Usual Audiological Rehabilitation in the Management of Tinnitus Related Insomnia
- ClinicalTrials.gov ID
- NCT03386123
- Acronym / sponsor ID
- UCLondonH
- Keywords
- Tinnitus, Insomnia, Cognitive Behaviour Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- British Tinnitus Association, University College, London
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 10 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 29 Dec 2017 (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.
There is evidence that CBT for insomnia (CBTi) is an effective treatment for sleep disturbance both as a primary problem and when co-morbid with other health problems, such as chronic pain.
This study will investigate the effectiveness of CBTi as a treatment for tinnitus related insomnia. Tinnitus patients reporting clinically significant insomnia will be offered sleep-specific treatment. Six sessions of CBTi will be offered to one group of patients and 2 sessions standard audiological care (psycho-education and sleep hygiene) will be offered to another group. Both groups will be offered sound enrichment at night. In order to take account of the possible effects of clinical contact a third group will be offered 6 sessions of support without a focused tinnitus or sleep intervention. Accepted measures of sleep disturbance will be used as well as measures of tinnitus complaint.
All treatment/contact will be provided at the Royal National Throat Nose \& Ear Hospital. Participants will be involved in the study (inc. baseline period {2 weeks}, intervention {8 weeks} and follow-ups {4 and 20 weeks}) for 34 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behaviour Therapy for Insomnia (CBTi) | Experimental | Behavioral: Cognitive Behaviour Therapy for InsomniaA standard CBTi programme for the treatment of primary insomnia, with six, 2 hour, group sessions over eight weeks. There will be minor adaptations for tinnitus, including making specific reference to tinnitus and psycho-education about tinnitus. Every session concludes with provision of a homework task and a sleep diary to complete over the next week. The CBTi course will be supported by providing participants with a CD with some relaxation exercises and a booklet that covers the information given in the session. CBTi includes: Sleep restriction, stimulus control, Sleep hygiene, Relaxation training, Paradoxical intention, Cognitive therapy: Targeting unhelpful beliefs about sleep and worry, Behavioural experiments: Testing unhelpful beliefs and adjusting sleep related behaviour. |
| Standard Audiological Care (SAC) | Active comparator | Behavioral: Standard Audiological CareA group intervention that fits with reported audiological treatment of people with tinnitus and significant sleep impairment. This involves psycho-education about tinnitus, habituation, sleep and sleep hygiene. Relaxation will be advised and information provided. A bedside sound generator, as used in routine clinical practice will be provided. Information will be based on standard advice given by hearing therapists/audiologists and will not include specific psychological techniques which are not part of SAC. The group will be generally supportive. SAC tends not to involve repeated meetings; after the initial session, there will be one follow up session 8 weeks later. Follow up will allow for question and answer, and reports on what has been useful. Both sessions will last for 2 hours |
| Sleep Support Group (SSG) | Placebo comparator | Behavioral: Sleep Support GroupParticipants will meet in a group, which will offer equivalent contact with therapists and a supportive group milieu as CBTi. It will focus on the potential benefits of a supportive group and will not include specific advice. Participants will complete 2-week sleep diaries as baseline and outcome measures at the four time-points, which will be checked within the session to ensure that participants know how to complete them correctly. The SSG will meet in a group for six sessions, over eight weeks, each of 2 two hours duration. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least moderately distressing tinnitus (above a set minimum score on the Mini TQ) for at least six months and problematic insomnia (above a set minimum score on the Insomnia Severity Index (ISI) and for tinnitus related insomnia to be identified in clinical interview) as result of tinnitus, for at least three months.
- Patient wishes to work on improving sleep.
- Sufficient understanding of English and sufficient hearing ability to take part in for group discussions and to complete questionnaires.
- Patient has had tinnitus assessed by a doctor and an audiological specialist.
- Willing and able to provide written consent. Able to regularly attend clinic in London, United Kingdom.
Key exclusion criteria (5 listed)
- • Organic sleep disorders present (e.g. Obstructive Sleep Apnoea, delayed phase sleep, etc.) assessed with a subscale of the hospital sleep unit's sleep disorder and snoring proforma.
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 |
|---|---|---|
| Cognitive Behaviour Therapy for InsomniaContinuous maintenance of sleep diary, cognitive behaviour therapy, including cognitive restructuring, and behavioural change focusing on sleep restriction and safety behaviours. | Behavioural | Cognitive Behaviour Therapy for Insomnia (CBTi) |
| Standard Audiological CareMaintenance of sleep diary at key times. Psycho-education, provision of bedside sound generator. | Behavioural | Standard Audiological Care (SAC) |
| Sleep Support GroupMaintenance of sleep diary at key times. Social support focused on tinnitus and sleep problems. | Behavioural | Sleep Support Group (SSG) |
Primary outcome
Change in Insomnia Severity Index (ISI) score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
7-item questionnaire, each item rates 0 - 4. Total scores range from 0-28 with higher scores indicating more severity.
Change in the amount of sleep obtained
Time frame: A 2-week sleep diary will be kept 2 weeks prior to the first and last treatment sessions and to the 1 and 6 month follow-ups.
Average of all of the following metrics obtained from 2 weeks of sleep diary measure: Sleep Onset Latency - lower score indicates better sleep; Wake Time After Sleep Onset - lower score indicate better sleep; Number of night time awakenings - lower scores indicate better sleep; Total Sleep Time - higher scores indicate better sleep; Time in Bed - included only so that Sleep Efficiency can be calculated: Sleep Efficiency (Total Sleep Time / Time in Bed x 100) - higher scores indicate better sleep. Diary measures for sleep quality (0= worst possible to 10=best possible), tinnitus annoyance (0= not at all to 10= extremely), refreshed at waking (0= not at all to 10= very refreshed) and quality of day time functioning (0= very poor to 10= very good).
12 secondary outcomes
Change in Pittsburgh Sleep Quality Index score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Dysfunctional Beliefs and Attitudes About Sleep Questionnaire - abbreviated version (DBAS-16) score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Tinnitus Catastrophizing Scale score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Mini Tinnitus Questionnaire score
Time frame: Screening
Change in the Tinnitus Questionnaire score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in subjective measure of tinnitus loudness
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Clinical Outcome in Routine Evaluation - Outcome Measure score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Patient Health Questionnaire-9 score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Generalized Anxiety Disorder Assessment-7 score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in EuroQOL score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Change in Work and Social Adjustment Scale score
Time frame: At first and last treatment sessions and at 1 and 6 month follow-ups
Satisfaction and feedback
Time frame: At the end of treatment and at six month follow-up point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Derived from this study: PubMed 36645178Cramer L, Vogt F, McKenna L, Marks E. How people with tinnitus-related insomnia experience group CBT-for-insomnia (CBTi): a thematic analysis. Int J Audiol. 2024 Mar;63(3):190-198. doi: 10.1080/14992027.2022.2161016. Epub 2023 Jan 16.
- Derived from this study: PubMed 31791396Marks E, Hallsworth C, McKenna L. Cognitive behavioural therapy for insomnia (CBTi) as a treatment for tinnitus-related insomnia: protocol for a randomised controlled trial. Trials. 2019 Dec 2;20(1):667. doi: 10.1186/s13063-019-3778-5.
- 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.
Laurence Laurence, PhD principal investigator
University College London Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behaviour Therapy for Insomnia, Standard Audiological Care and Sleep Support Group in people with Tinnitus and Insomnia, run by University College London Hospitals at 1 site in United Kingdom.
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 5 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: status not confirmed, as of the sponsor's last update on 10 Jun 2019. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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?
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 Insomnia Severity Index (ISI) score (time frame: At first and last treatment sessions and at 1 and 6 month follow-ups). The study lists 2 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 NCT03386123, which also lists 2 linked publications.
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 10 Jun 2019.