InsomniaPhase 3Sleep-HDNCT03534284
Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis
A Phase 3 study testing Cognitive Behavioral Therapy for Insomnia and Trazodone in people with Insomnia and End Stage Renal Disease, run by University of Washington at 1 site in United States.
Trial summary
Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, End Stage Renal Disease
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia and Trazodone
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Sep 2018to 17 Nov 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing thrice-weekly maintenance hemodialysis for ≥ 3 months
- Able to speak English
- ISI score ≥ 10 at pre-screening with sleep disturbances for ≥ 3 nights per week for ≥ 3 months
Who cannot join
- Severe cognitive impairment on Mini-COG cognitive test (score < 3)
- Severe depression assessed by Patient Health Questionnaire (PHQ)-2 and if appropriate, PHQ-9
- Suicidal Ideation
- Alcohol abuse on CAGE alcohol assessment questionnaire (score ≥ 2) or substance abuse on Drug Abuse Screening Test (DAST)-10 questionnaire (score > 5)
- Severe restless leg syndrome
- Treatment with trazodone in the past one month
Show all 14Show fewer
- Known allergy to trazodone (self-report or by chart review)
- Current treatment with monoamine oxidase inhibitors or in the preceding 14 days
- Current treatment with linezolid (self-report or by chart review)
- Current treatment with other drugs that are inhibitors of CYP3A4 (e.g., itraconazole, clarithromycin, voriconazole), or known to prolong QT interval including Class 1A antiarrhythmics (e.g., quinidine, procainamide) or Class 3 antiarrhythmics (e.g., amiodarone, sotalol), antipsychotic medications (ziprasidone, chlorpromazine, thioridazine), and quinolone antibiotics
- Pregnancy, or lactation, or women of childbearing potential not willing to use adequate birth control
- Life Expectancy < 3 months
- Expected to receive a kidney transplant or transition to home dialysis (peritoneal dialysis or home hemodialysis) within 6 months
- Any other condition that, in the opinion of the investigator, should preclude patient participation in the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)
Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months.
The SLEEP-HD study is a randomized open-label clinical trial to compare two types of treatment for insomnia in participants who have end-stage renal disease on HD, and who have been diagnosed with chronic insomnia. The two types of treatment involved in the study are Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs placebo).
126 participants will be enrolled who are undergoing HD in two study locations (Seattle, Washington and Albuquerque, New Mexico).
Read the detailed description
Most HD patients have significant impairments in quality of life, largely from the high frequency of disabling symptoms. Insomnia is one of the most frequently reported symptoms and studies of HD patients and/or other populations suggest that it is a significant contributor to other common symptoms and poor health outcomes. There are unique contributors to chronic insomnia in HD patients and these include the biologic effects of residual uremia after partial correction as is achieved with current dialysis technology, maladaptation to treatment schedules, and patients' napping during treatments.
There is a compelling need to identify effective treatments for insomnia in HD patients and the interventions being studied in this clinical trial, telehealth cognitive behavioral therapy for insomnia (CBT-I) and trazodone, have a strong scientific premise. If telehealth (web-based) CBT-I is effective for insomnia in HD patients, it will make a treatment that is presently inaccessible available to patients. Trazodone is widely used but the data on efficacy for insomnia are limited; no such data exist for HD patients.
SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
- Conditions
- Insomnia, End Stage Renal Disease
- Being tested
- Cognitive Behavioral Therapy for Insomnia, Trazodone, Placebo
- Keywords
- Hemodialysis, Kidney disease, Trazodone, Cognitive behavioral therapy
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Kidney Failure, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for InsomniaBehavioural
Also called CBT-I
Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
TrazodoneDrug
Also called Desyrel
trazodone tablet
PlaceboDrug
Also called Placebo (for trazodone)
Inactive pill manufactured to mimic trazodone tablets.
| Study group | Role | What they receive |
|---|---|---|
| CBT-I | Active comparator | Cognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks. Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia |
| Medication- Trazodone | Active comparator | Trazodone (50-100 mg): Receives: Drug: Trazodone |
| Medication- Placebo | Placebo comparator | Placebo (for trazodone) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI) Short-term
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Insomnia Severity Index (ISI) Long-term
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Secondary outcomes (22)
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term
Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term
Score from Pittsburgh Sleep Quality Index, measuring sleep quality, range 0 to 21. Higher scores indicates worse sleep quality: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term
Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term
Score from Epworth Sleepiness Scale, measuring sleepiness, range 0 to 24. Higher scores indicates greater sleepiness: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term
Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term
Score from FACIT Fatigue Scale, measuring fatigue, range 0 to 52. Higher scores indicates greater fatigue: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term
Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term
Score from first item Graded Chronic Pain scale, measuring pain, range 0 to 10. Higher scores indicates greater pain: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term
Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term
Score from Second Item Graded Chronic Pain scale, measuring pain interference, range 0 to 10. Higher scores indicates greater interference from pain: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term
Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term
Score from Patient Health Questionnaire 9, measuring depression, range 0 to 27. Higher scores indicates greater depression: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term
Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term
Score from Generalized Anxiety Disorder 7 Scale, measuring anxiety, range 0 to 21. Higher scores indicates greater anxiety: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term
Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term
Score from Quality of Life Short Form 12 scale - Physical Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term
Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term
Score from Quality of Life Short Form 12 scale - Mental Component Score, measuring quality of life, range 0 to 100. Higher scores indicates better quality of life: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Cumulative Weekly Use of Sedatives/Hypnotics - Short-term
This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Cumulative Weekly Use of Sedatives/Hypnotics - Long-term
This will be defined, as the number of days that the patient took a drug to help sleep, range from 0 to 7: at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Objective Measure of Sleep - Short-term
Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 7 describing the short-term effect of the intervention
Measured: Week 7
Objective Measure of Sleep - Long-term
Actigraphy measurement of average nighttime sleep efficiency (percent time asleep of time in bed): at Week 25 describing the long-term effect of the intervention
Measured: Week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2018
- Study start19 Sep 2018
- Primary completion17 Oct 2022
- Study completion17 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajnish Mehrotra, University of Washington
- Investigators
- Raj Mehrotra, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03534284
- Sponsor's protocol ID
- STUDY00004678
- Other IDs
- R01DK115468
- Acronym
- Sleep-HD
- Status last verified
- Feb 2024
- First submitted
- 1 May 2018
- Last updated
- 5 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehrotra R, Cukor D, McCurry SM, Rue T, Roumelioti ME, Heagerty PJ, Unruh M. Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial. Ann Intern Med. 2024 Feb;177(2):177-188. doi: 10.7326/M23-1794. Epub 2024 Jan 16.
PubMed 38224591Unruh M, Cukor D, Rue T, Abad K, Roumelioti ME, McCurry SM, Heagerty P, Mehrotra R. Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis. BMC Nephrol. 2020 Oct 20;21(1):443. doi: 10.1186/s12882-020-02107-x.
PubMed 33081705
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short and Long-Term Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis (Sleep-HD)
- ClinicalTrials.gov ID
- NCT03534284
- Acronym / sponsor ID
- Sleep-HD / STUDY00004678
- Conditions
- Insomnia, End Stage Renal Disease
- Keywords
- Hemodialysis, Kidney disease, Trazodone, Cognitive behavioral therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 17 Oct 2022 (actual)
- Study completion
- 17 Nov 2022 (actual)
- First posted
- 23 May 2018 (actual)
- Results
- Posted 5 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insomnia is a common and distressing symptom for patients on hemodialysis (HD), and there is evidence for a much larger impact on the health of patients. Chronic insomnia is disrupted sleep that occurs at least three nights per week and lasts at least three months.
The SLEEP-HD study is a randomized open-label clinical trial to compare two types of treatment for insomnia in participants who have end-stage renal disease on HD, and who have been diagnosed with chronic insomnia. The two types of treatment involved in the study are Cognitive Behavioral Therapy for Insomnia (CBT-I) or treatment with a drug (trazodone vs placebo).
126 participants will be enrolled who are undergoing HD in two study locations (Seattle, Washington and Albuquerque, New Mexico).
Detailed description
Most HD patients have significant impairments in quality of life, largely from the high frequency of disabling symptoms. Insomnia is one of the most frequently reported symptoms and studies of HD patients and/or other populations suggest that it is a significant contributor to other common symptoms and poor health outcomes. There are unique contributors to chronic insomnia in HD patients and these include the biologic effects of residual uremia after partial correction as is achieved with current dialysis technology, maladaptation to treatment schedules, and patients' napping during treatments.
There is a compelling need to identify effective treatments for insomnia in HD patients and the interventions being studied in this clinical trial, telehealth cognitive behavioral therapy for insomnia (CBT-I) and trazodone, have a strong scientific premise. If telehealth (web-based) CBT-I is effective for insomnia in HD patients, it will make a treatment that is presently inaccessible available to patients. Trazodone is widely used but the data on efficacy for insomnia are limited; no such data exist for HD patients.
SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- SLEEP-HD is a parallel group randomized controlled trial wherein 125 HD patients with chronic insomnia, treated in community-based dialysis facilities in Seattle and Albuquerque, will be randomized 1:1:1 over 31 months to 6-week treatment with telehealth CBT-I, trazodone, or medication placebo.
| Arm | Type | Receives |
|---|---|---|
| CBT-I | Active comparator | Behavioral: Cognitive Behavioral Therapy for InsomniaCognitive Behavioral Therapy for Insomnia sessions: a 30-minute treatment session once weekly for six weeks. |
| Medication- Trazodone | Active comparator | Drug: TrazodoneTrazodone (50-100 mg): |
| Medication- Placebo | Placebo comparator | Drug: PlaceboPlacebo (for trazodone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Undergoing thrice-weekly maintenance hemodialysis for ≥ 3 months
- Able to speak English
- ISI score ≥ 10 at pre-screening with sleep disturbances for ≥ 3 nights per week for ≥ 3 months
Key exclusion criteria (14 listed)
- Severe cognitive impairment on Mini-COG cognitive test (score < 3)
- Severe depression assessed by Patient Health Questionnaire (PHQ)-2 and if appropriate, PHQ-9
- Suicidal Ideation
- Alcohol abuse on CAGE alcohol assessment questionnaire (score ≥ 2) or substance abuse on Drug Abuse Screening Test (DAST)-10 questionnaire (score > 5)
- Severe restless leg syndrome
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 Behavioral Therapy for InsomniaAlso: CBT-IOnce weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform. | Behavioural | CBT-I |
| TrazodoneAlso: Desyreltrazodone tablet | Drug | Medication- Trazodone |
| PlaceboAlso: Placebo (for trazodone)Inactive pill manufactured to mimic trazodone tablets. | Drug | Medication- Placebo |
Primary outcome
Insomnia Severity Index (ISI) Short-term
Time frame: Week 7
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 7 describing the short-term effect of the intervention
Insomnia Severity Index (ISI) Long-term
Time frame: Week 25
summary score obtained from the ISI, measuring insomnia, range from 0 to 28. Higher score indicates greater insomnia, at Week 25 describing the long-term effect of the intervention
22 secondary outcomes
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - Pittsburgh Sleep Quality Index - Long-term
Time frame: Week 25
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - Epworth Sleepiness Scale - Long-term
Time frame: Week 25
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - FACIT Fatigue Scale- Long-term
Time frame: Week 25
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Long-term
Time frame: Week 25
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - Graded Chronic Pain Scale - Interference - Long-term
Time frame: Week 25
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - Patient Health Questionnaire 9 - Long-term
Time frame: Week 25
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - Generalized Anxiety Disorder 7 Scale - Long-term
Time frame: Week 25
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Physical Component Score - Long-term
Time frame: Week 25
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Short-term
Time frame: Week 7
Patient-reported Outcomes (PRO) - Quality of Life Short Form 12 Scale - Mental Component Score - Long-term
Time frame: Week 25
Cumulative Weekly Use of Sedatives/Hypnotics - Short-term
Time frame: Week 7
Cumulative Weekly Use of Sedatives/Hypnotics - Long-term
Time frame: Week 25
Objective Measure of Sleep - Short-term
Time frame: Week 7
Objective Measure of Sleep - Long-term
Time frame: Week 25
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38224591Mehrotra R, Cukor D, McCurry SM, Rue T, Roumelioti ME, Heagerty PJ, Unruh M. Effectiveness of Existing Insomnia Therapies for Patients Undergoing Hemodialysis : A Randomized Clinical Trial. Ann Intern Med. 2024 Feb;177(2):177-188. doi: 10.7326/M23-1794. Epub 2024 Jan 16.
- Derived from this study: PubMed 33081705Unruh M, Cukor D, Rue T, Abad K, Roumelioti ME, McCurry SM, Heagerty P, Mehrotra R. Sleep-HD trial: short and long-term effectiveness of existing insomnia therapies for patients undergoing hemodialysis. BMC Nephrol. 2020 Oct 20;21(1):443. doi: 10.1186/s12882-020-02107-x.
- 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.
Raj Mehrotra, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cognitive Behavioral Therapy for Insomnia and Trazodone in people with Insomnia and End Stage Renal Disease, run by University of Washington at 1 site in United States.
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 14 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 5 Feb 2024. 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 States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Insomnia Severity Index (ISI) Short-term (time frame: Week 7). 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 NCT03534284, 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 5 Feb 2024.