NCT02599701

Acute Effects of Gabapentin in Sleep Parameters and Hormonal Release During Sleep in Older Men

Acute Effects of Gabapentin on Polysomnography Parameters and on Hypothalamic-pituitary-adrenal, Hypothalamic-pituitary-gonadal and Somatotropic Axes During Sleep in Older Men: a Randomized, Double-blind, Placebo-controlled Trial

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Associação Fundo de Incentivo à Pesquisa · Academic / Other
• Sex: Male
• Age: 60 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the effects of gabapentin in sleep polysomnography parameters and in nocturnal secretion of endogenous hypothalamic-pituitary-adrenal (HPA), hypothalamic-pituitary-gonadal (HPG) and somatotropic axes hormones and basal IGF-1 in older men.

Detailed description

The influence of sleep variables on muscle protein anabolism is little studied, but data on the effects of slow-wave sleep and the syndrome of obstructive sleep apnea on the hypothalamic-pituitary axis indicate that interventions in the sleep structure and disorders impact on the age-related muscle loss. Thus, we propose to assess the acute effects of a drug potentially capable of increasing slow wave sleep, and consequently growth hormone release during sleep, on the physiological release of growth hormone, testosterone and IGF-1 during the night in older healthy men.

Conditions

• Sleep

Interventions

Type	Name	Description
DRUG	Gabapentin	A single dose Gabapentin 300mg at bedtime.
DRUG	Placebo	A single placebo dose with the same physical characteristics of the active intervention.

Timeline

• Start date: 2015-09-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-11-09
• Last updated: 2016-07-13

Locations

1 site across 1 country: Brazil