Melatonin's Effect on Nighttime Blood Pressure and Sleep in OSA Patients (MEBP-OSA)

NCT06380491 | Recruiting Phase 4 DMC

• 2 other identifiers: REF.2338UNAM-PAPIIT 32-IN216919
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if melatonin works to treat comorbid insomnia in adults with OSA and nocturnal non-dipping blood pressure pattern. The main question it aims to answer is: Does melatonin maintain sleep during night and recover the dipping blood pressure pattern?

Conditions

Obstructive Sleep Apnea of Adult

Keywords

Circadian Blood Pressure Rhythm; Obstructive sleep apnea; Melatonin

Outcome Measures

Primary Outcomes (1)

• Melatonin at a dose of 3 mg before sleep time, after a period of 30 days changes the time awake after sleep onset (WASO), and recovers the dipper pattern of blood pressure

  Wake after sleep onset (WASO) and non-dipper patter of Blood Pressure change after melatonin intake for 30 days

  30 days

Study Arms (2)

Usual care for nocturnal non-dipping Blood Pressurem in OSA

EXPERIMENTAL

1\. Group of participants receives an intervention/treatment considered to be usual care

Drug: Melatonin 3 MG Oral Tablet

Oral administration of 3 mg/day of melatonin for 30 days in non-dipping Blood Pressure in OSA

EXPERIMENTAL

2\. Group of participants receives oral Melatonin 3 mg/day during 30 days plus usual care

Drug: Melatonin 3 MG Oral Tablet

Interventions

Melatonin 3 MG Oral Tablet DRUG

Participants with OSA and nocturnal non-dipping Blood Pressure will be randomly assigned to a treatment with melatonin 3mg/d or to receive only the usual care.

Also known as: Usual Care for participants with OSA and nocturnal non-dipping Blood Pressure

Oral administration of 3 mg/day of melatonin for 30 days in non-dipping Blood Pressure in OSA; Usual care for nocturnal non-dipping Blood Pressurem in OSA

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Polisomnographic diagnosis of Obstructive Sleep Apnea
• Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):

You may not qualify if:

• Use of sleep or psychiatric medication
• Use of Positive Airway Pressure (CPAP or Bipap)
• Neurologic or psychiatric disorder

Sponsors & Collaborators

• Emory University: collaborator
• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• Universidad Nacional Autonoma de Mexico: collaborator

Study Sites (1)

National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)

Mexico City, Mexico

RECRUITING

Related Publications (22)

• Hermida RC, Ayala DE, Mojon A, Fernandez JR. Influence of circadian time of hypertension treatment on cardiovascular risk: results of the MAPEC study. Chronobiol Int. 2010 Sep;27(8):1629-51. doi: 10.3109/07420528.2010.510230.

  PMID: 20854139 RESULT

• Hermida RC, Ayala DE, Mojon A, Fernandez JR. Blunted sleep-time relative blood pressure decline increases cardiovascular risk independent of blood pressure level--the "normotensive non-dipper" paradox. Chronobiol Int. 2013 Mar;30(1-2):87-98. doi: 10.3109/07420528.2012.701127. Epub 2012 Oct 5.

  PMID: 23039824 RESULT

• O'Brien E, Sheridan J, O'Malley K. Dippers and non-dippers. Lancet. 1988 Aug 13;2(8607):397. doi: 10.1016/s0140-6736(88)92867-x. No abstract available.

  PMID: 2899801 RESULT

• Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ; National Heart, Lung, and Blood Institute Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; National High Blood Pressure Education Program Coordinating Committee. The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure: the JNC 7 report. JAMA. 2003 May 21;289(19):2560-72. doi: 10.1001/jama.289.19.2560. Epub 2003 May 14.

  PMID: 12748199 RESULT

• Boggia J, Li Y, Thijs L, Hansen TW, Kikuya M, Bjorklund-Bodegard K, Richart T, Ohkubo T, Kuznetsova T, Torp-Pedersen C, Lind L, Ibsen H, Imai Y, Wang J, Sandoya E, O'Brien E, Staessen JA; International Database on Ambulatory blood pressure monitoring in relation to Cardiovascular Outcomes (IDACO) investigators. Prognostic accuracy of day versus night ambulatory blood pressure: a cohort study. Lancet. 2007 Oct 6;370(9594):1219-29. doi: 10.1016/S0140-6736(07)61538-4.

  PMID: 17920917 RESULT

• Hansen TW, Li Y, Boggia J, Thijs L, Richart T, Staessen JA. Predictive role of the nighttime blood pressure. Hypertension. 2011 Jan;57(1):3-10. doi: 10.1161/HYPERTENSIONAHA.109.133900. Epub 2010 Nov 15.

  PMID: 21079049 RESULT

• Kario K, Kanegae H, Tomitani N, Okawara Y, Fujiwara T, Yano Y, Hoshide S. Nighttime Blood Pressure Measured by Home Blood Pressure Monitoring as an Independent Predictor of Cardiovascular Events in General Practice. Hypertension. 2019 Jun;73(6):1240-1248. doi: 10.1161/HYPERTENSIONAHA.118.12740.

  PMID: 31006331 RESULT

• de la Sierra A, Redon J, Banegas JR, Segura J, Parati G, Gorostidi M, de la Cruz JJ, Sobrino J, Llisterri JL, Alonso J, Vinyoles E, Pallares V, Sarria A, Aranda P, Ruilope LM; Spanish Society of Hypertension Ambulatory Blood Pressure Monitoring Registry Investigators. Prevalence and factors associated with circadian blood pressure patterns in hypertensive patients. Hypertension. 2009 Mar;53(3):466-72. doi: 10.1161/HYPERTENSIONAHA.108.124008. Epub 2009 Jan 26.

  PMID: 19171788 RESULT

• Eguchi K, Pickering TG, Hoshide S, Ishikawa J, Ishikawa S, Schwartz JE, Shimada K, Kario K. Ambulatory blood pressure is a better marker than clinic blood pressure in predicting cardiovascular events in patients with/without type 2 diabetes. Am J Hypertens. 2008 Apr;21(4):443-50. doi: 10.1038/ajh.2008.4. Epub 2008 Feb 21.

  PMID: 18292756 RESULT

• Fagard RH, Thijs L, Staessen JA, Clement DL, De Buyzere ML, De Bacquer DA. Night-day blood pressure ratio and dipping pattern as predictors of death and cardiovascular events in hypertension. J Hum Hypertens. 2009 Oct;23(10):645-53. doi: 10.1038/jhh.2009.9. Epub 2009 Feb 19.

  PMID: 19225527 RESULT

• Afsar B, Sezer S, Elsurer R, Ozdemir FN. Is HOMA index a predictor of nocturnal nondipping in hypertensives with newly diagnosed type 2 diabetes mellitus? Blood Press Monit. 2007 Jun;12(3):133-9. doi: 10.1097/MBP.0b013e3280b08379.

  PMID: 17496462 RESULT

• Loredo JS, Ancoli-Israel S, Dimsdale JE. Sleep quality and blood pressure dipping in obstructive sleep apnea. Am J Hypertens. 2001 Sep;14(9 Pt 1):887-92. doi: 10.1016/s0895-7061(01)02143-4.

  PMID: 11587154 RESULT

• American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019 Jan;42(Suppl 1):S13-S28. doi: 10.2337/dc19-S002.

  PMID: 30559228 RESULT

• Williams B, Mancia G, Spiering W, Agabiti Rosei E, Azizi M, Burnier M, Clement D, Coca A, De Simone G, Dominiczak A, Kahan T, Mahfoud F, Redon J, Ruilope L, Zanchetti A, Kerins M, Kjeldsen S, Kreutz R, Laurent S, Lip GYH, McManus R, Narkiewicz K, Ruschitzka F, Schmieder R, Shlyakhto E, Tsioufis K, Aboyans V, Desormais I; List of authors/Task Force members:. 2018 Practice Guidelines for the management of arterial hypertension of the European Society of Hypertension and the European Society of Cardiology: ESH/ESC Task Force for the Management of Arterial Hypertension. J Hypertens. 2018 Dec;36(12):2284-2309. doi: 10.1097/HJH.0000000000001961. No abstract available.

  PMID: 30379783 RESULT

• Gijon-Conde T, Gorostidi M, Banegas JR, de la Sierra A, Segura J, Vinyoles E, Divison-Garrote JA, Ruilope LM. [Position statement on ambulatory blood pressure monitoring (ABPM) by the Spanish Society of Hypertension (2019)]. Hipertens Riesgo Vasc. 2019 Oct-Dec;36(4):199-212. doi: 10.1016/j.hipert.2019.05.002. Epub 2019 Jun 6. Spanish.

  PMID: 31178410 RESULT

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  PMID: 21179973 RESULT

• Vaile JC, Stallard TJ, al-Ani M, Jordan PJ, Townend JN, Littler WA. Sleep and blood pressure: spontaneous baroreflex sensitivity in dippers and non-dippers. J Hypertens. 1996 Dec;14(12):1427-32. doi: 10.1097/00004872-199612000-00007.

  PMID: 8986925 RESULT

• Aung AT, Chan SP, Kyaing TT, Lee CH. Diabetes mellitus is associated with high sleep-time systolic blood pressure and non-dipping pattern. Postgrad Med. 2020 May;132(4):346-351. doi: 10.1080/00325481.2020.1745537. Epub 2020 Mar 24.

  PMID: 32208051 RESULT

• Nikolaidou B, Anyfanti P, Gavriilaki E, Lazaridis A, Triantafyllou A, Zarifis H, Mastrogiannis K, Tsapas A, Douma S, Gkaliagkousi E. Non-dipping pattern in early-stage diabetes: association with glycemic profile and hemodynamic parameters. J Hum Hypertens. 2022 Sep;36(9):805-810. doi: 10.1038/s41371-021-00587-4. Epub 2021 Aug 16.

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• Pinilla L, Benitez ID, Gracia-Lavedan E, Torres G, Minguez O, Aguila M, Targa A, Dalmases M, Mediano O, Masa JF, Masdeu MJ, Barbe F, Sanchez-de-la-Torre M. Polysomnographic characterization of circadian blood pressure patterns in patients with obstructive sleep apnea. Sleep. 2023 Apr 12;46(4):zsad031. doi: 10.1093/sleep/zsad031.

  PMID: 36806948 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Melatonin; Tablets

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Matilde Valencia-Flores, PhD

  National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matilde Valencia-Flores, PhD

CONTACT

(+52 55) 54870900; matilde.valenciaf@incmnsz.mx

Maria V Santiago, MSc

CONTACT

(+52 55) 54870900; victoria.santiagoa@incmnsz.mx

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator/ Head of the Sleep Disorders Clinic

Model Details: Patients with a non-dipper pattern in blood pressure will randomly enter one of two options: 1) usual medical treatment; 2) treatment with melatonin plus usual care.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: June 22, 2023
• Primary Completion (Estimated): December 22, 2027
• Study Completion (Estimated): January 22, 2028
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)