Effects of Melatonin in Untreated Obstructive Sleep Apnea

Status Terminated

Clinical Trial Summary

The investigators have previously shown that 1 week of 10mg Melatonin improves sleep consolidation in untreated obstructive sleep apnea (OSA) patients. This study aims to extend on those findings to determine if longer treatment of Melatonin improves other outcomes in untreated OSA patients.

Clinical Trial Description

Intermittent hypoxia (low oxygen), sleep fragmentation and restriction are characteristic of obstructive sleep apnea (OSA) and cause mental deficits and cardiovascular disease (CVD). Melatonin (MLT) is a hormone with sleep promoting properties and the investigators have found 7 days 10mg MLT treatment significantly increases sleep consolidation in untreated OSA. Thus, melatonin could improve mental function. MLT also has potent antioxidant, anti-inflammatory and anti-hypertensive properties. In humans with CVD and metabolic disorder exogenous MLT improves a wide range of cardio-metabolic outcomes. In rat models of OSA, MLT completely blocks intermittent hypoxia induced cardiovascular damage and brain cell death. Intermittent hypoxia also induces lasting changes in the neural control of breathing, which worsens OSA. Experimentally antioxidants block the induction of changes to neural control of breathing. Thus MLT may also normalize the control of breathing and reduce the severity of OSA. Given these findings, the hypothesis is that MLT will improve mental function, cardiovascular outcomes and control of breathing in untreated OSA. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03492736
Study type	Interventional
Source	University of California, San Diego
Contact
Status	Terminated
Phase	Early Phase 1
Start date	April 1, 2018
Completion date	October 1, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05857384` - Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs	Phase 1
Recruiting	`NCT04547543` - Follow-up of Apneic Patients by Visio-consultation	N/A
Recruiting	`NCT05371509` - Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study	N/A
Completed	`NCT02515357` - Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea	N/A
Completed	`NCT05582070` - Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction	N/A
Active, not recruiting	`NCT03189173` - Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea	Phase 2
Completed	`NCT04084899` - The Effect of CPAP on Lung Hyperinflation in Patients With OSA
Completed	`NCT03032029` - Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
Recruiting	`NCT04028011` - Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
Recruiting	`NCT06047353` - Community Health Advocates for Motivating PAP Use in Our Neighborhoods.	N/A
Completed	`NCT05253963` - Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea	N/A
Recruiting	`NCT06029959` - Stroke and CPAP Outcome Study 3	N/A
Recruiting	`NCT06150352` - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Completed	`NCT03589417` - Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
Recruiting	`NCT04335994` - ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing	N/A
Withdrawn	`NCT04063436` - Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea	N/A
Recruiting	`NCT05385302` - Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
Recruiting	`NCT04572269` - Metabolomics of Obstructive Sleep Apnea
Not yet recruiting	`NCT06467682` - 12-week Tele-exercise Program in Patients With OSA	N/A
Withdrawn	`NCT04011358` - Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study	N/A