InsomniaNCT03267537
Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia
A study testing Telemedicine CBT-I and Conventional office-based CBT-I in people with Insomnia, run by University of Arizona at 1 site in United States.
Trial summary
Insomnia is a common medical condition that has a deleterious effect on emotional status, health-related quality of life, and has been associated with hospitalizations and all-cause mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Telemedicine CBT-I and Conventional office-based CBT-I
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2017to 31 May 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically ill patients with recent hospitalization who are being discharged to home.
- ISI score of > 10 (chronic insomnia)
- Age > 18 years
- Ability to provide informed consent
- Willingness to undergo sleep study
Who cannot join
- Presence of untreated sleep disorder that requires treatment independent of insomnia (Narcolepsy, restless leg syndrome, or REM sleep behavior disorder)
- Patients with severe debilitating neurological disease (end-stage Alzheimer's, large stroke, or other debilitating neurological disease) or any other condition that renders patients incapable of providing informed consent
- History of Bipolar disease; current or past (< 6 months) history of suicidality or suicidal ideation
- Active substance abuse or alcoholism
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Arizona (Banner University Medical Center - Tucson & Banner University Medical Center - South)
Tucson, Arizona, 85721
Sairam Parthasarathy, MD, 520-626-6109, sparthasarathy@deptofmed.arizona.edu
Chris Morton, 5206268457, cjmorton@email.arizona.edu
About this study
Insomnia is a common medical condition that has a deleterious effect on emotional status, health-related quality of life, and has been associated with hospitalizations and all-cause mortality. Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the comfort of their homes via the wireless iPAD and video chat software. In patients who are recently discharged from the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services is an important area of future research.
Read the detailed description
Insomnia is a common and distressing medical condition that affects nearly 20% of U.S. adults, and persistent (or chronic) insomnia affects nearly 10-15% of U.S. adults. In a community-based prospective observational study, preliminary data suggests that insomnia is associated with hospitalizations due to cardiovascular, cancer, or any cause over a 4-year period. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the gold-standard in the treatment of insomnia. There are 5 components of CBT-I, sleep restriction therapy, stimulus control instructions, relaxation training, cognitive therapy, and sleep hygiene education. In an ongoing study of CBT-I in recently hospitalized patients, the investigators found a high prevalence of insomnia (80%) and were able to administer CBT-I in the participants' home via iPADs with wireless connectivity and secure video-chat software. Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the patient's homes via the wireless iPAD and video chat software. The AASM SleepTM platform could conceivably allow performance of CBT-I without the added expense of an iPAD. The investigators are proposing to perform a non-inferiority trial of telemedicine CBT-I (AASM SleepTM) versus conventional office-based CBT-I that is performed in patients with insomnia who have been recently discharged from the hospital. The investigators will measure the following outcomes: insomnia severity index (primary outcome) and patient satisfaction. In the future, the investigators' program of research aims to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services.
Specific Aim 1: To perform comparative effectiveness research of CBT-I administered by telemedicine versus conventional office-based CBT-I on insomnia severity in recently hospitalized patients.
Hypothesis #1: In recently hospitalized patients with insomnia, after six weeks of CBT-I treatment, the mean improvement in ISI score among patients treated by telemedicine CBT-I (AASM SleepTM) would be no more than 3-points less than that in patients treated by conventional office-based CBT-I.
Specific Aim 2: To perform comparative effectiveness research of CBT-I administered by telemedicine versus conventional office-based CBT-I on patient satisfaction.
Hypothesis #2: In recently hospitalized patients with insomnia, after six weeks of CBT-I treatment, the mean improvement in patient satisfaction score (Consumer Assessment of Health Plans Survey [CAHPS v4.0] item) among patients treated by telemedicine CBT-I (AASM SleepTM) would be no more than 1-point less than that in patients treated by conventional office-based CBT-I.
- Conditions
- Insomnia
- Being tested
- Telemedicine CBT-I, Conventional office-based CBT-I
- Keywords
- Insomnia, Sleep, Telemedicine
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine CBT-IBehavioural
Will be administered in a manner similar to the conventional CBT-I arm except that the patient would not be required to make office visits
Conventional office-based CBT-IBehavioural
Conventional office-based CBT-I
| Study group | Role | What they receive |
|---|---|---|
| Conventional office-based CBT-I | Active comparator | CBT-I will be delivered by a licensed clinical psychologist in weekly sessions lasting up to 1 hour. There will be 6 CBT-I sessions over the course of therapy with the option of an additional 2 treatments if deemed necessary by the clinical psychologist. Receives: Behavioral: Conventional office-based CBT-I |
| Telemedicine based CBT-I | Experimental | The treatment will be the exact same as the active comparator group, with the same clinical psychologist doing the office-based CBT-I, but will be administered through a telemedicine modality Receives: Behavioral: Telemedicine CBT-I |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem \& 4=very severe problem) Change in ISI score will be assessed between baseline and following CBT-I treatment over a 6 week period.
Measured: Baseline and after receiving CBT-I (~6 weeks)
Secondary outcomes (1)
Consumer Assessment of Health Plans Survey (CAHPS v4.0) item
Health plan member's satisfaction with care on 0 to 10 scale (0 is the "worst " and 10 is the "best health plan possible"). Change in CAHPS score will be measured
Measured: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2017
- Study start13 Jun 2017
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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 ArizonaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Responsible party
- Principal investigator, Sairam Parthasarathy, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267537
- Sponsor's protocol ID
- 1545864655443n/a
- Status last verified
- Aug 2017
- First submitted
- 14 Jun 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193.
PubMed 23423416Kyle SD, Morgan K, Espie CA. Insomnia and health-related quality of life. Sleep Med Rev. 2010 Feb;14(1):69-82. doi: 10.1016/j.smrv.2009.07.004. Epub 2009 Dec 4.
PubMed 19962922Parthasarathy S, Vasquez MM, Halonen M, Bootzin R, Quan SF, Martinez FD, Guerra S. Persistent insomnia is associated with mortality risk. Am J Med. 2015 Mar;128(3):268-75.e2. doi: 10.1016/j.amjmed.2014.10.015. Epub 2014 Oct 16.
PubMed 25447616Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.
PubMed 7481413Althuis MD, Fredman L, Langenberg PW, Magaziner J. The relationship between insomnia and mortality among community-dwelling older women. J Am Geriatr Soc. 1998 Oct;46(10):1270-3. doi: 10.1111/j.1532-5415.1998.tb04544.x.
PubMed 9777910Newman AB, Spiekerman CF, Enright P, Lefkowitz D, Manolio T, Reynolds CF, Robbins J. Daytime sleepiness predicts mortality and cardiovascular disease in older adults. The Cardiovascular Health Study Research Group. J Am Geriatr Soc. 2000 Feb;48(2):115-23. doi: 10.1111/j.1532-5415.2000.tb03901.x.
PubMed 10682939Rockwood K, Davis HS, Merry HR, MacKnight C, McDowell I. Sleep disturbances and mortality: results from the Canadian Study of Health and Aging. J Am Geriatr Soc. 2001 May;49(5):639-41. doi: 10.1046/j.1532-5415.2001.49125.x.
PubMed 11380758Nilsson PM, Nilsson JA, Hedblad B, Berglund G. Sleep disturbance in association with elevated pulse rate for prediction of mortality--consequences of mental strain? J Intern Med. 2001 Dec;250(6):521-9. doi: 10.1046/j.1365-2796.2001.00913.x.
PubMed 11902821Mallon L, Broman JE, Hetta J. Sleep complaints predict coronary artery disease mortality in males: a 12-year follow-up study of a middle-aged Swedish population. J Intern Med. 2002 Mar;251(3):207-16. doi: 10.1046/j.1365-2796.2002.00941.x.
PubMed 11886479Suzuki E, Yorifuji T, Ueshima K, Takao S, Sugiyama M, Ohta T, Ishikawa-Takata K, Doi H. Sleep duration, sleep quality and cardiovascular disease mortality among the elderly: a population-based cohort study. Prev Med. 2009 Aug-Sep;49(2-3):135-41. doi: 10.1016/j.ypmed.2009.06.016. Epub 2009 Jun 30.
PubMed 19573557Rod NH, Vahtera J, Westerlund H, Kivimaki M, Zins M, Goldberg M, Lange T. Sleep disturbances and cause-specific mortality: Results from the GAZEL cohort study. Am J Epidemiol. 2011 Feb 1;173(3):300-9. doi: 10.1093/aje/kwq371. Epub 2010 Dec 30.
PubMed 21193534Almeida OP, Alfonso H, Yeap BB, Hankey G, Flicker L. Complaints of difficulty to fall asleep increase the risk of depression in later life: the health in men study. J Affect Disord. 2011 Nov;134(1-3):208-16. doi: 10.1016/j.jad.2011.05.045. Epub 2011 Jun 15.
PubMed 21680026Eaker ED, Pinsky J, Castelli WP. Myocardial infarction and coronary death among women: psychosocial predictors from a 20-year follow-up of women in the Framingham Study. Am J Epidemiol. 1992 Apr 15;135(8):854-64. doi: 10.1093/oxfordjournals.aje.a116381.
PubMed 1585898Vgontzas AN, Liao D, Pejovic S, Calhoun S, Karataraki M, Basta M, Fernandez-Mendoza J, Bixler EO. Insomnia with short sleep duration and mortality: the Penn State cohort. Sleep. 2010 Sep;33(9):1159-64. doi: 10.1093/sleep/33.9.1159.
PubMed 20857861Li Y, Zhang X, Winkelman JW, Redline S, Hu FB, Stampfer M, Ma J, Gao X. Association between insomnia symptoms and mortality: a prospective study of U.S. men. Circulation. 2014 Feb 18;129(7):737-46. doi: 10.1161/CIRCULATIONAHA.113.004500. Epub 2013 Nov 13.
PubMed 24226807
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-inferiority Study of Telemedicine Versus Conventional CBT-I in Recently Hospitalized Patients With Insomnia
- ClinicalTrials.gov ID
- NCT03267537
- Acronym / sponsor ID
- 1545864655443n/a
- Conditions
- Insomnia
- Keywords
- Insomnia, Sleep, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- American Academy of Sleep Medicine
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 30 Aug 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.
Insomnia is a common medical condition that has a deleterious effect on emotional status, health-related quality of life, and has been associated with hospitalizations and all-cause mortality. Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the comfort of their homes via the wireless iPAD and video chat software. In patients who are recently discharged from the hospital, we wish to assess whether telemedicine-based CBT-I is comparable to conventional office-based CBT-I in the efficacy for treating insomnia. Research aiming to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services is an important area of future research.
Detailed description
Insomnia is a common and distressing medical condition that affects nearly 20% of U.S. adults, and persistent (or chronic) insomnia affects nearly 10-15% of U.S. adults. In a community-based prospective observational study, preliminary data suggests that insomnia is associated with hospitalizations due to cardiovascular, cancer, or any cause over a 4-year period. Cognitive Behavioral Therapy for Insomnia (CBT-I) is considered the gold-standard in the treatment of insomnia. There are 5 components of CBT-I, sleep restriction therapy, stimulus control instructions, relaxation training, cognitive therapy, and sleep hygiene education. In an ongoing study of CBT-I in recently hospitalized patients, the investigators found a high prevalence of insomnia (80%) and were able to administer CBT-I in the participants' home via iPADs with wireless connectivity and secure video-chat software. Recently hospitalized patients who are recuperating in their homes would find it difficult to return for weekly visits with a clinical psychologist and therefore could benefit from the convenience of CBT-I treatment administered in the patient's homes via the wireless iPAD and video chat software. The AASM SleepTM platform could conceivably allow performance of CBT-I without the added expense of an iPAD. The investigators are proposing to perform a non-inferiority trial of telemedicine CBT-I (AASM SleepTM) versus conventional office-based CBT-I that is performed in patients with insomnia who have been recently discharged from the hospital. The investigators will measure the following outcomes: insomnia severity index (primary outcome) and patient satisfaction. In the future, the investigators' program of research aims to improve understanding of whether insomnia represents a modifiable risk factor for re-hospitalizations in patients who are high utilizers of healthcare services.
Specific Aim 1: To perform comparative effectiveness research of CBT-I administered by telemedicine versus conventional office-based CBT-I on insomnia severity in recently hospitalized patients.
Hypothesis #1: In recently hospitalized patients with insomnia, after six weeks of CBT-I treatment, the mean improvement in ISI score among patients treated by telemedicine CBT-I (AASM SleepTM) would be no more than 3-points less than that in patients treated by conventional office-based CBT-I.
Specific Aim 2: To perform comparative effectiveness research of CBT-I administered by telemedicine versus conventional office-based CBT-I on patient satisfaction.
Hypothesis #2: In recently hospitalized patients with insomnia, after six weeks of CBT-I treatment, the mean improvement in patient satisfaction score (Consumer Assessment of Health Plans Survey [CAHPS v4.0] item) among patients treated by telemedicine CBT-I (AASM SleepTM) would be no more than 1-point less than that in patients treated by conventional office-based CBT-I.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Conventional office-based CBT-I | Active comparator | Behavioral: Conventional office-based CBT-ICBT-I will be delivered by a licensed clinical psychologist in weekly sessions lasting up to 1 hour. There will be 6 CBT-I sessions over the course of therapy with the option of an additional 2 treatments if deemed necessary by the clinical psychologist. |
| Telemedicine based CBT-I | Experimental | Behavioral: Telemedicine CBT-IThe treatment will be the exact same as the active comparator group, with the same clinical psychologist doing the office-based CBT-I, but will be administered through a telemedicine modality |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Medically ill patients with recent hospitalization who are being discharged to home.
- ISI score of > 10 (chronic insomnia)
- Age > 18 years
- Ability to provide informed consent
- Willingness to undergo sleep study
Key exclusion criteria (5 listed)
- Presence of untreated sleep disorder that requires treatment independent of insomnia (Narcolepsy, restless leg syndrome, or REM sleep behavior disorder)
- Patients with severe debilitating neurological disease (end-stage Alzheimer's, large stroke, or other debilitating neurological disease) or any other condition that renders patients incapable of providing informed consent
- History of Bipolar disease; current or past (< 6 months) history of suicidality or suicidal ideation
- Active substance abuse or alcoholism
- Pregnancy or lactation
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 |
|---|---|---|
| Telemedicine CBT-IWill be administered in a manner similar to the conventional CBT-I arm except that the patient would not be required to make office visits | Behavioural | Telemedicine based CBT-I |
| Conventional office-based CBT-IConventional office-based CBT-I | Behavioural | Conventional office-based CBT-I |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Baseline and after receiving CBT-I (~6 weeks)
A 7-item questionnaire used to assess insomnia severity with a score ranging between 0 to 28. Each questionnaire item addresses an aspect about sleep that is rated by the respondent on a 5-point scale (i.e., 0=no problem \& 4=very severe problem) Change in ISI score will be assessed between baseline and following CBT-I treatment over a 6 week period.
1 secondary outcome
Consumer Assessment of Health Plans Survey (CAHPS v4.0) item
Time frame: Administered at baseline and at the end of receiving CBT-I (~6 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 23423416Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193.
- Background: PubMed 19962922Kyle SD, Morgan K, Espie CA. Insomnia and health-related quality of life. Sleep Med Rev. 2010 Feb;14(1):69-82. doi: 10.1016/j.smrv.2009.07.004. Epub 2009 Dec 4.
- Background: PubMed 25447616Parthasarathy S, Vasquez MM, Halonen M, Bootzin R, Quan SF, Martinez FD, Guerra S. Persistent insomnia is associated with mortality risk. Am J Med. 2015 Mar;128(3):268-75.e2. doi: 10.1016/j.amjmed.2014.10.015. Epub 2014 Oct 16.
- Background: PubMed 7481413Foley DJ, Monjan AA, Brown SL, Simonsick EM, Wallace RB, Blazer DG. Sleep complaints among elderly persons: an epidemiologic study of three communities. Sleep. 1995 Jul;18(6):425-32. doi: 10.1093/sleep/18.6.425.
- Background: PubMed 9777910Althuis MD, Fredman L, Langenberg PW, Magaziner J. The relationship between insomnia and mortality among community-dwelling older women. J Am Geriatr Soc. 1998 Oct;46(10):1270-3. doi: 10.1111/j.1532-5415.1998.tb04544.x.
- Background: PubMed 10682939Newman AB, Spiekerman CF, Enright P, Lefkowitz D, Manolio T, Reynolds CF, Robbins J. Daytime sleepiness predicts mortality and cardiovascular disease in older adults. The Cardiovascular Health Study Research Group. J Am Geriatr Soc. 2000 Feb;48(2):115-23. doi: 10.1111/j.1532-5415.2000.tb03901.x.
- Background: PubMed 11380758Rockwood K, Davis HS, Merry HR, MacKnight C, McDowell I. Sleep disturbances and mortality: results from the Canadian Study of Health and Aging. J Am Geriatr Soc. 2001 May;49(5):639-41. doi: 10.1046/j.1532-5415.2001.49125.x.
- Background: PubMed 11902821Nilsson PM, Nilsson JA, Hedblad B, Berglund G. Sleep disturbance in association with elevated pulse rate for prediction of mortality--consequences of mental strain? J Intern Med. 2001 Dec;250(6):521-9. doi: 10.1046/j.1365-2796.2001.00913.x.
- Background: PubMed 11886479Mallon L, Broman JE, Hetta J. Sleep complaints predict coronary artery disease mortality in males: a 12-year follow-up study of a middle-aged Swedish population. J Intern Med. 2002 Mar;251(3):207-16. doi: 10.1046/j.1365-2796.2002.00941.x.
- Background: PubMed 19573557Suzuki E, Yorifuji T, Ueshima K, Takao S, Sugiyama M, Ohta T, Ishikawa-Takata K, Doi H. Sleep duration, sleep quality and cardiovascular disease mortality among the elderly: a population-based cohort study. Prev Med. 2009 Aug-Sep;49(2-3):135-41. doi: 10.1016/j.ypmed.2009.06.016. Epub 2009 Jun 30.
- Background: PubMed 21193534Rod NH, Vahtera J, Westerlund H, Kivimaki M, Zins M, Goldberg M, Lange T. Sleep disturbances and cause-specific mortality: Results from the GAZEL cohort study. Am J Epidemiol. 2011 Feb 1;173(3):300-9. doi: 10.1093/aje/kwq371. Epub 2010 Dec 30.
- Background: PubMed 21680026Almeida OP, Alfonso H, Yeap BB, Hankey G, Flicker L. Complaints of difficulty to fall asleep increase the risk of depression in later life: the health in men study. J Affect Disord. 2011 Nov;134(1-3):208-16. doi: 10.1016/j.jad.2011.05.045. Epub 2011 Jun 15.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine CBT-I and Conventional office-based CBT-I in people with Insomnia, run by University of Arizona 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 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 1 Sep 2017. 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. 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?
Contact Sairam Parthasarathy, MD ((520) 626-6109, sparthasarathy@deptofmed.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Baseline and after receiving CBT-I (~6 weeks)). 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 NCT03267537, which also lists 21 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 1 Sep 2017.