Effects of Melatonin in Untreated Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Does Melatonin Improve Neurocognitive Function, Cardiovascular Outcomes and Control of Breathing in Untreated Obstructive Sleep Apnea?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03492736
• Other study ID #: 180013
• Status: Terminated
• Phase: Early Phase 1
• Start date: April 1, 2018
• Est. completion date: October 1, 2018

Study information

• Verified date: January 2019
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

Inclusion Criteria:

• moderate-severe OSA (AHI =15/hr)

Exclusion Criteria:

• non-English speakers (due to necessity to complete neurocognitive testing)

• other sleep disorders

• history of driving or other accidents due to sleepiness or an Epworth score (ESS)> 18

• pregnant

• smokers (quit = 1 year ago acceptable)

• diabetes

• cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease

• Substantial alcohol (>3oz/day) or use of illicit drugs

• psychiatric disorders (other than depression or anxiety)

• current MLT use or use within last 6 months

• beta blockers, central nervous system depressants or stimulants, anti-inflammatories, anticoagulants, immunosuppressants, vitamins, antioxidants.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Dietary Supplement:
• Melatonin
30 days 10mg Melatonin taken nightly 1 hour before bed

Other:
• Placebo
30 days placebo taken nightly 1 hour before bed

Locations

Country	Name	City	State
United States	University of California, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Naomi Deacon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hypoxic ventilatory response	change in ventilation per change in expiratory CO2 during sustained hypoxia	baseline versus on the 30th day of treatment
Primary	PHQ-9 score	9 Questions relating to depressive symptoms. Answers to each question rank from 0-3. Minimum total score = 0, maximum total score = 27, with >=10 indicating clinically significant moderate severity depressive symptoms.	baseline versus on the 30th day of treatment
Secondary	Reactive Hyperemia Index	Endothelial function is calculated as the ratio between the magnitude of the mean post-occlusion pulse wave amplitude and mean baseline pulse wave amplitude.	baseline versus on the 30th day of treatment