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

Obstructive Sleep Apnea of Adult Clinical Trial

— MEBP-OSA  

Official title:

Impact of Melatonin Treatment on Blood Pressure Circadian Rhythm, Sleep and Metabolic Variables.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380491
• Other study ID #: REF.2338
• Secondary ID: UNAM-PAPIIT 32-I
• Status: Recruiting
• Phase: Phase 4
• Start date: June 22, 2023
• Est. completion date: January 22, 2025

Study information

• Verified date: April 2024
• Source: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
• Contact: Matilde Valencia-Flores, PhD
• Phone: (+52 55) 54870900
• Email: matilde.valenciaf[@]incmnsz.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 22, 2025
• Est. primary completion date: November 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Polisomnographic diagnosis of Obstructive Sleep Apnea

• Non-dipping blood pressure on Ambulatory blood pressure monitoring (ABPM):

Exclusion Criteria:

• Use of sleep or psychiatric medication

• Use of Positive Airway Pressure (CPAP or Bipap)

• Neurologic or psychiatric disorder

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Melatonin 3 MG Oral Tablet
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.

Locations

Country	Name	City	State
Mexico	National Institute of Medical Sciences and Nutrition Salvador Zubirán (INCMNSZ)	Mexico City

Sponsors (3)

Lead Sponsor	Collaborator
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran	Emory University, Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (22)

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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 r — View Citation

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 — View Citation

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. — View Citation

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 I — View Citation

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 Hyperten — View Citation

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. — View Citation

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 Oc — View Citation

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. — View Citation

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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, Ruschitz — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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