drugset / Trial / NCT02599701
Acute Effects of Gabapentin in Sleep Parameters and Hormonal Release During Sleep in Older Men
RandomizedCrossoverDouble-blindTreatment
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.
Timeline
- Start
- 2015-09
- Primary completion
- 2015-11
- Completion
- 2015-12
Publications
- Background Giannoulis MG, Martin FC, Nair KS, Umpleby AM, Sonksen P. Hormone replacement therapy and physical function in healthy older men. Time to talk hormones? Endocr Rev. 2012 Jun;33(3):314-77. doi: 10.1210/er.2012-1002. Epub 2012 Mar 20.
- Background Giustina A, Veldhuis JD. Pathophysiology of the neuroregulation of growth hormone secretion in experimental animals and the human. Endocr Rev. 1998 Dec;19(6):717-97. doi: 10.1210/edrv.19.6.0353.
- Background Dattilo M, Antunes HK, Medeiros A, Monico Neto M, Souza HS, Tufik S, de Mello MT. Sleep and muscle recovery: endocrinological and molecular basis for a new and promising hypothesis. Med Hypotheses. 2011 Aug;77(2):220-2. doi: 10.1016/j.mehy.2011.04.017. Epub 2011 May 7.
- Background Penev P, Spiegel K, L'Hermite-Baleriaux M, Schneider R, Van Cauter E. Relationship between REM sleep and testosterone secretion in older men. Ann Endocrinol (Paris). 2003 Apr;64(2):157. No abstract available.
- Background Van Cauter E, Latta F, Nedeltcheva A, Spiegel K, Leproult R, Vandenbril C, Weiss R, Mockel J, Legros JJ, Copinschi G. Reciprocal interactions between the GH axis and sleep. Growth Horm IGF Res. 2004 Jun;14 Suppl A:S10-7. doi: 10.1016/j.ghir.2004.03.006.
- Background Saletu M, Anderer P, Saletu-Zyhlarz GM, Parapatics S, Gruber G, Nia S, Saletu B. Comparative placebo-controlled polysomnographic and psychometric studies on the acute effects of gabapentin versus ropinirole in restless legs syndrome. J Neural Transm (Vienna). 2010 Apr;117(4):463-73. doi: 10.1007/s00702-009-0361-3. Epub 2010 Jan 5.
- Background Foldvary-Schaefer N, De Leon Sanchez I, Karafa M, Mascha E, Dinner D, Morris HH. Gabapentin increases slow-wave sleep in normal adults. Epilepsia. 2002 Dec;43(12):1493-7. doi: 10.1046/j.1528-1157.2002.21002.x.
- Background Rosenberg KP. Gabapentin for chronic insomnia. Am J Addict. 2003 May-Jun;12(3):273-4. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gabapentin | Small molecule | 300 mg | — |
Indications
No indication recorded.