Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia

Zeitzer, Jamie M.; Ku, Ban; Ota, Doug; Kiratli, B. Jenny

doi:10.1179/2045772313y.0000000099

Cited by 12 publications

(5 citation statements)

References 37 publications

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“…In any case, people with tetraplegia suffer sleep problems and poor quality of life [44]; moreover, these problems associated to the increased metabolic disorders (as described in the Introduction) place them in an increased risk for suffering stroke or myocardial infarction. Despite that a pilot clinical trial [45], carried out in eight patients with tetraplegia and absence of MT production, in which sleep disorders existed, showed that treating them with 8 mg of the MT agonist Ramelteon did not produce significant effects on the existing sleep problems, we think that the reported multiple beneficial effects of MT, and the absence of any adverse effect that it might produce, make this hormone useful when treating SCI patients. This is the reason by which we administered oral MT (at doses no lesser than 50 mg/ day) to any SCI patient being treated in the Medical Center Foltra.…”

Section: Discussionmentioning

confidence: 81%

Is the Use of Growth hormone and Melatonin Justified in Spinal Cord Injuries?

Devesa¹,

Segade²,

JacoboIsorna³

et al. 2017

MOJAP

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In this review we analyzed the possibility that tetraplegic patients suffer a deficient GH secretion occurring as a consequence of the loss of adrenergic control of somatostatin release, the inhibitor of pituitary GH synthesis and release. A deficient GH secretion can contribute to enhance the metabolic abnormalities seen in tetraplegics, increase the cardiovascular risk and osteopenia/osteoporosis. We also analyzed why orthostatic hypotension exists in tetraplegics, because of the loss of sympathetic afferences to the cardiovascular system. In addition we examined why the pineal production of melatonin is absent in tetraplegics, as a result of the loss of adrenergic signals from the upper cervical ganglion to the pineal gland; this results in sleep disorders and poor quality of life, but also in increased oxidative stress and the loss of the multiple beneficious effects that melatonin plays in the human body (oncostatic, anti-inflammatory, neuroprotective, etc). Lastly we describe a case of exaggerated allergic response to an allergen in a young tetraplegic girl. We conclude that because of the decreased production of the natural inhibitors of histamine (adrenaline and ACTH-independent corticosteroids), tetraplegic patients may have a special enhanced sensitivity to allergens that should be studied. In summary, GH and Melatonin are useful and safe in the treatment of tetraplegic patients.

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Section: Discussionmentioning

confidence: 81%

Is the Use of Growth hormone and Melatonin Justified in Spinal Cord Injuries?

Devesa¹,

Segade²,

JacoboIsorna³

et al. 2017

MOJAP

View full text Add to dashboard Cite

show abstract

“…Some studies reported changes of the scores of SF-36 components after the administration of melatonin. Melatonin was reported to improve QOL, as assessed using the SF-36, in patients with primary insomnia and delayed sleep phase syndrome [48, 49], whereas no improvement in the QOL was observed in patients with tetraplegia and chronic fatigue syndrome [50, 51]. There have been no previous reports on the effects of ramelteon on health-related QOL of patients, regardless of diabetes; accordingly, this is the first report on the effect of ramelteon assessed using SF-36.…”

Section: Discussionmentioning

confidence: 99%

The Effects of Ramelteon on Glucose Metabolism and Sleep Quality in Type 2 Diabetic Patients With Insomnia: A Pilot Prospective Randomized Controlled Trial

et al. 2016

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BackgroundInsomnia is associated with the onset and development of diabetes. Melatonin affects sleep quality and glucose metabolism in diabetic patients with insomnia. We administered ramelteon, an agonist of melatonin, to type 2 diabetic patients and investigated its effects on glucose metabolism and insomnia.MethodsThis multicenter, prospective, randomized, and observational pilot study was performed between April 2014 and April 2015 at three institutes in Japan. Patients were prescribed ramelteon 8 mg/day for 3 months (first period). And patients were divided at random into the continuation group that continued taking ramelteon and the discontinuation group that discontinued taking ramelteon for 3 additional months (second period). The primary endpoint was change in glycated hemoglobin (HbA1c) level. Secondary endpoints were changes in global Pittsburgh sleep questionnaire index (PSQI) score and other glucose metabolism makers.ResultsWe enrolled 42 patients, and 32 patients completed the first period. Their mean HbA1c was 6.7%, and global PSQI score was 8.1 on average. HbA1c level did not change but global PSQI score improved from 8.1 to 7.2 by ramelteon (P = 0.030). Thirty-one patients completed the second period. HbA1c level did not change in the continuation group, but it increased from 6.7% to 6.9% (P = 0.003) in the discontinuation group. Global PSQI score did not change in each group. There was no rebound insomnia.ConclusionTreatment with ramelteon did not change the HbA1c level but improved sleep quality in type 2 diabetic patients with insomnia. Discontinuation of ramelteon slightly increased the HbA1c level and did not worsen sleep quality.

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“…A small size pilot study71 and two subsequent randomized controlled, cross-over trials72,104 have demonstrated the safety of exogenous melatonin in tetraplegia. While the studies suggested some subjective improvements in sleep, both trials were underpowered statistically to demonstrate any effect on objective sleep variables.…”

Section: Management Of Sleep Disorders In Individuals With Scimentioning

confidence: 99%

<p>Impact Of Spinal Cord Injury On Sleep: Current Perspectives</p>

Sankari¹,

Badr²,

Martin³

et al. 2019

NSS

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Sleep disorders are commonly encountered in people living with spinal cord injury (SCI). Primary sleep disorders such as sleep-disordered breathing (SDB), sleep-related movement disorders, circadian rhythm sleep-wake disorders, and insomnia disorder are common conditions after SCI but remain under-recognized, underdiagnosed and therefore remain untreated for a majority of patients. Sleep disturbances in people living with SCI are associated with significant impairments of daytime function and quality of life. Previous reviews have described findings related mainly to SDB but have not examined the relationship between other sleep disorders and SCI. This narrative review examines various sleep abnormalities and related functional and physical impairments in people living with SCI. It discusses new evidence pertaining to management, highlights existing limitations in the literature and recommends future directions for research.

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Randomized controlled trial of pharmacological replacement of melatonin for sleep disruption in individuals with tetraplegia

Abstract: In this pilot study, we were unable to show effectiveness of pharmacological replacement of melatonin for the treatment of self-reported sleep problems in individuals with tetraplegia. Trial Registration ClinicalTrials.gov # NCT00507546.

Cited by 12 publications

References 37 publications

Is the Use of Growth hormone and Melatonin Justified in Spinal Cord Injuries?

Is the Use of Growth hormone and Melatonin Justified in Spinal Cord Injuries?

The Effects of Ramelteon on Glucose Metabolism and Sleep Quality in Type 2 Diabetic Patients With Insomnia: A Pilot Prospective Randomized Controlled Trial

<p>Impact Of Spinal Cord Injury On Sleep: Current Perspectives</p>

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