The Effect of Melatonin on Sleep and Ventilatory Control in Obstructive Sleep Apnea

Completed · Not applicable · Has a placebo group

Conditions studied: Obstructive Sleep Apnea

In brief

Our hypothesis is that oxidative stress induced during repeated apneas in obstructive sleep apnea (OSA) patients alters the neural control of breathing which destabilizes ventilatory control and exacerbates OSA. Thus antioxidant treatment has the potential to reduce OSA severity. Melatonin is a hormone which regulates sleep patterns, but it is also a potent antioxidant. Melatonin production is suppressed when the eyes register light so people with healthy sleep exhibit a peak in blood serum levels around 2am which then decreases towards morning. OSA patients exhibit lower melatonin levels with a later peak around 6am which then extends later into the day. This abnormal pattern is thought to compound difficulty falling asleep and daytime mental fatigue. Therefore the potential benefits of melatonin treatment in OSA patients are two-fold: most importantly via its antioxidant actions melatonin may reduce chemoreflex sensitivity, stabilize ventilatory control and reduce OSA severity; by normalizing sleep phase melatonin may also allow patients to fall asleep easier and wake more refreshed.

Key facts

Study ID

NCT02484300

Run by

University of California, San Diego

People needed

20

Starts

2015-07-01

Expected to finish

2017-11-01

Last updated by the study team

2020-12-22

Who can join

Age: 18 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Male
• Ages 18-70 years
• No other sleep disorders
• Severe OSA (≥30 apnea hypopnea index)

You may not qualify if…

• Females
• Smokers (quit ≥ 1 year ago acceptable)
• Abnormal lung function (FEV1 and FVC < 80% predicted)
• Any known cardiac (apart from treated hypertension with acceptable drugs, see below), pulmonary (including asthma), renal, neurologic (including epilepsy), neuromuscular, hepatic disease, or patients with diabetes.
• History of driving or other accidents due to sleepiness or an ESS > 18.
• Prior or current use of melatonin.
• Use of serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, ACE inhibitors or any drugs which interfere with the renin-Angiotensin system, Losartan (or other Angiotensin II type 1 receptor antagonists), non-specific calcium channel blockers (L channel specific are acceptable), anti-inflammatories, vitamins or any antioxidants.
• Use of any medications that may affect sleep or breathing.
• A psychiatric disorder, other than mild depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
• Substantial alcohol (>3oz/day) or use of illicit drugs.
• More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.

Where it is running

• University of California, San Diego — San Diego, California, United States

Full record on ClinicalTrials.gov

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