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RecruitingNCT06380491MEBP-OSAUpdated Apr 1, 2026

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

A Phase 4 interventional study of Melatonin 3 MG Oral Tablet in Obstructive Sleep Apnea of Adult, sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran. Recruiting at 1 site in Mexico. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jun 2023, registered Apr 2024).
  • Started Jun 2023; still recruiting 3 years 4 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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?

Read the detailed description

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?

Participants will:

  • Take melatonin or the habitual treatment every day for one month
  • Visit the clinic 11 times for one month
  • Keep a diary of their symptom and activities and use twice a 24 h ambulatory blood pressure monitoring (ABPM), attend two overnight polysomnography studies, and use an actigraph every day for 2 weeks.

Researchers will compare melatonin to the habitual treatment to see if melatonin works to treat insomnia and recover the dipping blood pressure pattern.

The medical problems that participants would have when taking melatonin are:

  • changes in blood pressure and cholesterol
  • Increased risk of contracting immune system disorders
  • Possible increased risk of liver damage.
02

Conditions studied

  • Obstructive Sleep Apnea of Adult

Keywords

  • Circadian Blood Pressure Rhythm
  • Obstructive sleep apnea
  • Melatonin
03

In context

Sleep Apnea, Obstructive

2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.

This study's planned enrollment of 50 is close to the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran is the lead sponsor of 144 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Use of sleep or psychiatric medication
  • Use of Positive Airway Pressure (CPAP or Bipap)
  • Neurologic or psychiatric disorder
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Usual care for nocturnal non-dipping Blood Pressurem in OSA

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

    Drug: Melatonin 3 MG Oral Tablet

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

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

    Drug: Melatonin 3 MG Oral Tablet

Interventions

  • 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

06

What researchers measure

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

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)
    Mexico City, Mexico
    Recruiting
08

References and documents

Publications

  • 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. PubMed 20854139 ↗
  • 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. PubMed 23039824 ↗
  • 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. PubMed 2899801 ↗
  • 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. PubMed 12748199 ↗
  • 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. PubMed 17920917 ↗
  • 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. PubMed 21079049 ↗
  • 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. PubMed 31006331 ↗
  • 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. PubMed 19171788 ↗
  • 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. PubMed 18292756 ↗
  • 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. PubMed 19225527 ↗
  • 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. PubMed 17496462 ↗
  • 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. PubMed 11587154 ↗
  • 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. PubMed 30559228 ↗
  • 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. PubMed 30379783 ↗
  • 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. PubMed 31178410 ↗
  • Bastos JM, Bertoquini S, Polonia J. Prognostic significance of ambulatory arterial stiffness index in hypertensives followed for 8.2 years: its relation with new events and cardiovascular risk estimation. Rev Port Cardiol. 2010 Sep;29(9):1287-303. English, Portuguese. PubMed 21179973 ↗
  • 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. PubMed 8986925 ↗
  • 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. PubMed 32208051 ↗
  • 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. PubMed 34400769 ↗
  • Pio-Abreu A, Moreno H Jr, Drager LF. Obstructive sleep apnea and ambulatory blood pressure monitoring: current evidence and research gaps. J Hum Hypertens. 2021 Apr;35(4):315-324. doi: 10.1038/s41371-020-00470-8. Epub 2021 Jan 7. PubMed 33414503 ↗
  • Cuspidi C, Tadic M, Sala C, Gherbesi E, Grassi G, Mancia G. Blood Pressure Non-Dipping and Obstructive Sleep Apnea Syndrome: A Meta-Analysis. J Clin Med. 2019 Sep 2;8(9):1367. doi: 10.3390/jcm8091367. PubMed 31480717 ↗
  • 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. PubMed 36806948 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06380491
Collaborators
Universidad Nacional Autonoma de Mexico, Emory University
Responsible party
Matilde Valencia-Flores (Coordinator/ Head of the Sleep Disorders Clinic, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran) — Principal investigator
First posted
Apr 24, 2024
Start date
Jun 22, 2023
Primary completion
Dec 22, 2027 (estimated)
Completion
Jan 22, 2028 (estimated)
Last update
Apr 1, 2026

Study contacts

Matilde Valencia-Flores, PhD
Contact
matilde.valenciaf@incmnsz.mx
(+52 55) 54870900 ext. 3056
Maria V Santiago, MSc
Contact
victoria.santiagoa@incmnsz.mx
(+52 55) 54870900 ext. 3052
Matilde Valencia-Flores, PhD
principal investigator · National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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