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InsomniaPhase 4Print-HASNCT05414864

Insomnia Prevalence and Treatment Impact on Systemic Hypertension

A Phase 4 study testing Ramelteon (RozeremR) and sleep hygiene in people with Insomnia and Hypertension, run by University of Sao Paulo at 1 site in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Insomnia is defined as some difficulty in sleep onset, consolidation, duration, or quality, despite appropriate opportunities for getting sleep. In the last decade, there is growing evidence associating insomnia and high blood pressure, (HBP), coronary disease, heart failure, atrial fibrillation, as well as with an… Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Insomnia, Hypertension
What is being tested?
Ramelteon (RozeremR) and sleep hygiene
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteBrazil
Study dates
1 May 2022to 30 Sep 2022
Phase
Phase 4
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 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • BMI <40Kg/m2;
  • Availability to participate
  • History of HBP under regular treatment (systolic pressure between 130-160 and diastolic pressure between 80-100 mmHg).

Who cannot join

  • Use of benzodiazepines or "Z" drugs;
  • Night workers;
  • History of severe chronic obstructive pulmonary disease (COPD);
  • Heart failure (ejection fraction <40% on echocardiogram);
  • Prior stroke;
  • Generalized anxiety disorder (GAD-7 >14 points) and severe depression (Beck);
Show all 18Show fewer
  • Severe liver disease;
  • Alcohol abuse;
  • Advanced chronic kidney disease 4 or 5 (glomerular filtration rate <30ml/min/1.73m2);
  • Patient who is on loop diuretics;
  • Patient with type 1 diabetes;
  • Patient with decompensated type 2 diabetes (Glycated hemoglobin >8%);
  • Urinuria Incontinence;
  • Prostatism;
  • History of active cancer;
  • Pregnancy;
  • Complex sleep behaviors, suicidal behavior;
  • Other formal labeled contraindications, including a history of angioedema with ramelteone and patients using fluvoxamine (a strong inhibitor of CYP1A2)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Heart Institute (InCor)

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

About this study

Insomnia is defined as some difficulty in sleep onset, consolidation, duration, or quality, despite appropriate opportunities for getting sleep. In the last decade, there is growing evidence associating insomnia and high blood pressure, (HBP), coronary disease, heart failure, atrial fibrillation, as well as with an increased mortality rate. Despite the previously mentioned advances, the real impact of insomnia on HBP is unknown. It is unclear whether the diagnosis and pharmacologic treatment of insomnia will have an impact on 24-h BP. The aim of this study is to outline the prevalence of insomnia in patients with HBP followed in the ambulatories from the Hypertension Units at InCor and Hospital das Clínicas. The main hypothesis is that the prevalence of insomnia is high and most patients remain undiagnosed and consequently untreated. For this phase, up to 1,500 patients with HBP will be selected. Besides the medical records with demographic and anthropometric data, personal and familiar background, as well as regular medication, all patients will perform three systematic and standardized blood pressure checks on electric monitors.

Read the detailed description

Prevalence of insomnia in patients with HBP The aim of this study is to outline the prevalence of insomnia in patients with HBP followed by the outpatients' clinics at the InCor and Hospital das Clínicas. The main hypothesis is that the prevalence of insomnia is high and most patients remain undiagnosed and consequently untreated. For this phase, up to 1,500 patients with HBP will be recruited. Besides the medical records with demographic and anthropometric data, personal and familiar background, as well as regular medication, all patients will perform three systematic and standardized blood pressure checks on electric monitors. The average of the second and third checks will be the final result.

Furthermore, the following exams will be made:

  1. Definition of the presence of insomnia following the criteria from DSM V and filling up the insomnia severity index.
  2. Evaluation of the Pittsburgh Sleep Quality Index.
  3. Evaluation of obstructive sleep apnea by NoSAS score.
  4. Evaluation of daytime sleepiness by the Epworth Sleepiness Scale.
  5. Filling the DDAS form for evaluation of perception and impact of insomnia on the life of HBP patients.
  6. Filling the Beck form for depression evaluation.

The clinical characteristics of HBP patients with and without insomnia will be compared testing the hypothesis that patients with insomnia will be under more blood pressure medications and/or uncontrolled bllod pressure than patients without insomnia. If positive, a multivariate analysis will be performed for adjusting for counfonding factors.

Being tested
Ramelteon (RozeremR), sleep hygiene
Keywords
insomnia, hypertension, Ramelteon, sleep hygiene
Medical subject headings
Sleep Initiation and Maintenance Disorders, Hypertension, Sleep Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ramelteon (RozeremR)Drug

    8mg daily

  • sleep hygieneBehavioural

    sleep behavioral guidelines

Study groups in NCT05414864
Study groupRoleWhat they receive
Control GroupOtherSleep hygiene alone (control group)
Receives: Behavioral: sleep hygiene
Intervention GroupOtherSleep Hygiene and Ramelteone (RozeremTM) 8 mg at night
Receives: Drug: Ramelteon (RozeremR); Behavioral: sleep hygiene

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring)

    To assess the impact of treatment of early insomnia with ramelteon on daytime and nighttime blood presure (in mmHg) in hypertensive patients on 24-hour evaluation of ambulatory blood pressure monitoring.

    Measured: 3 months

Secondary outcomes (4)

  1. Efficacy of insomnia treatment on blood pressure (evaluated by office blood pressure)

    To evaluate the impact of treating initial insomnia with ramelteone on office blood pressure in hypertensive patients on office blood pressure (in mmHg)

    Measured: 3 months

  2. Efficacy of insomnia treatment on Sleep duration

    To assess the impact of treating insomnia with ramelteon in hypertensive patients on sleep duration evaluated by actigraphy (and reported in minutes of sleep);

    Measured: 3 months

  3. Efficacy of insomnia treatment on sleep quality

    To evaluate the impact of treating insomnia with ramelteon in hypertensive patients on sleep quality;

    Measured: 3 months

  4. Efficacy of insomnia treatment on subgroups of patients (intending to be a sub-study)

    Assess whether the pressure response of insomnia treatment on the primary and secondary outcomes is mediated by the presence of obstructive sleep apnea.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start1 May 2022
  3. Primary completion31 Jul 2022
  4. Study completion30 Sep 2022

Why it stopped: Takeda suspended financial support. The first phase (observational study) is ongoing.

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05414864
Sponsor's protocol ID
5276/21/051
Acronym
Print-HAS
Status last verified
Jul 2022
First submitted
5 May 2022
Last updated
29 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Schutte-Rodin S, Broch L, Buysse D, Dorsey C, Sateia M. Clinical guideline for the evaluation and management of chronic insomnia in adults. J Clin Sleep Med. 2008 Oct 15;4(5):487-504.

    PubMed 18853708

  • Ford ES, Cunningham TJ, Giles WH, Croft JB. Trends in insomnia and excessive daytime sleepiness among U.S. adults from 2002 to 2012. Sleep Med. 2015 Mar;16(3):372-8. doi: 10.1016/j.sleep.2014.12.008. Epub 2015 Jan 14.

    PubMed 25747141

  • Roth T, Coulouvrat C, Hajak G, Lakoma MD, Sampson NA, Shahly V, Shillington AC, Stephenson JJ, Walsh JK, Kessler RC. Prevalence and perceived health associated with insomnia based on DSM-IV-TR; International Statistical Classification of Diseases and Related Health Problems, Tenth Revision; and Research Diagnostic Criteria/International Classification of Sleep Disorders, Second Edition criteria: results from the America Insomnia Survey. Biol Psychiatry. 2011 Mar 15;69(6):592-600. doi: 10.1016/j.biopsych.2010.10.023. Epub 2010 Dec 31.

    PubMed 21195389

  • Pearson NJ, Johnson LL, Nahin RL. Insomnia, trouble sleeping, and complementary and alternative medicine: Analysis of the 2002 national health interview survey data. Arch Intern Med. 2006 Sep 18;166(16):1775-82. doi: 10.1001/archinte.166.16.1775.

    PubMed 16983058

  • Castro LS, Poyares D, Leger D, Bittencourt L, Tufik S. Objective prevalence of insomnia in the Sao Paulo, Brazil epidemiologic sleep study. Ann Neurol. 2013 Oct;74(4):537-46. doi: 10.1002/ana.23945. Epub 2013 Sep 16.

    PubMed 23720241

  • Javaheri S, Redline S. Insomnia and Risk of Cardiovascular Disease. Chest. 2017 Aug;152(2):435-444. doi: 10.1016/j.chest.2017.01.026. Epub 2017 Jan 30.

    PubMed 28153671

  • Fernandez-Mendoza J, Vgontzas AN, Liao D, Shaffer ML, Vela-Bueno A, Basta M, Bixler EO. Insomnia with objective short sleep duration and incident hypertension: the Penn State Cohort. Hypertension. 2012 Oct;60(4):929-35. doi: 10.1161/HYPERTENSIONAHA.112.193268. Epub 2012 Aug 14.

    PubMed 22892811

  • Vgontzas AN, Liao D, Bixler EO, Chrousos GP, Vela-Bueno A. Insomnia with objective short sleep duration is associated with a high risk for hypertension. Sleep. 2009 Apr;32(4):491-7. doi: 10.1093/sleep/32.4.491.

    PubMed 19413143

  • Suka M, Yoshida K, Sugimori H. Persistent insomnia is a predictor of hypertension in Japanese male workers. J Occup Health. 2003 Nov;45(6):344-50. doi: 10.1539/joh.45.344.

    PubMed 14676413

  • Laugsand LE, Vatten LJ, Platou C, Janszky I. Insomnia and the risk of acute myocardial infarction: a population study. Circulation. 2011 Nov 8;124(19):2073-81. doi: 10.1161/CIRCULATIONAHA.111.025858. Epub 2011 Oct 24.

    PubMed 22025601

  • Mallon 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 11886479

  • Laugsand LE, Strand LB, Platou C, Vatten LJ, Janszky I. Insomnia and the risk of incident heart failure: a population study. Eur Heart J. 2014 Jun 1;35(21):1382-93. doi: 10.1093/eurheartj/eht019. Epub 2013 Mar 5.

    PubMed 23462728

  • Han X, Yang Y, Chen Y, Gao L, Yin X, Li H, Qiu J, Wang Y, Zhou Y, Xia Y. Association between insomnia and atrial fibrillation in a Chinese population: A cross-sectional study. Clin Cardiol. 2017 Sep;40(9):765-769. doi: 10.1002/clc.22731. Epub 2017 May 31.

    PubMed 28561943

  • Li 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

  • McGrath ER, Espie CA, Power A, Murphy AW, Newell J, Kelly C, Duffy N, Gunning P, Gibson I, Bostock S, O'Donnell MJ. Sleep to Lower Elevated Blood Pressure: A Randomized Controlled Trial (SLEPT). Am J Hypertens. 2017 Mar 1;30(3):319-327. doi: 10.1093/ajh/hpw132.

    PubMed 28391289

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ramelteon (RozeremR) and sleep hygiene in people with Insomnia and Hypertension, run by University of Sao Paulo at 1 site in Brazil.

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 18 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: stopped early, as of the sponsor's last update on 29 Dec 2022. 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 Brazil. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Takeda suspended financial support. The first phase (observational study) is ongoing.). 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?

Efficacy of insomnia treatment on blood pressure (evaluated by Ambulatory blood pressure monitoring) (time frame: 3 months). 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 NCT05414864, 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 29 Dec 2022.

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