Sleep Wake and Melatonin Pattern in Craniopharyngioma

Sleep Disorders, Circadian Rhythm Clinical Trial

Official title:

Cross Sectional Study of Sleep-wake and Melatonin Patterns in Patients Treated for Craniopharyngiomas Compared to Matched Controls

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01881854
• Other study ID #: Cranio-sleep-melatonin
• Status: Completed
• Phase: N/A
• First received: June 12, 2013
• Last updated: February 21, 2017
• Start date: November 2011
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The hypothalamus is a part of the brain containing a number of nuclei with a variety of functions. It is central in the regulation of hormone secretion, sleep, and circadian functions. The suprachiasmatic nucleus of the hypothalamus is a key component in controlling circadian rhythms and generates the rhythm of melatonin secretion from the pineal gland and cortisol secretion. Both melatonin and cortisol are involved in the regulation of circadian rhythms and sleep.

Craniopharyngiomas are a type of brain tumors that usually affect the hypothalamus indirectly. In general, they are locally aggressive invading crucial structures e.g. the hypothalamus, the pituitary, and the optic nerve. Compared to healthy controls, craniopharyngioma patients have previously been reported with impaired quality of life, increased self-reported general and physical fatigue, increased daytime sleepiness, and increased prevalence of severe sleepiness

Damage to the hypothalamus by local tumour or its treatment might involve the suprachiasmatic nucleus and thereby melatonin secretion leading to disturbed circadian function causing clinical manifestations in terms of daytime sleepiness and fatigue.

The investigators aimed to assess the influence of craniopharyngiomas or their treatment on melatonin secretion, and the association with sleep pattern, sleep quality, fatigue, and sleepiness.

15 patients with craniopharyngioma and 15 gender, age, and BMI matched healthy controls were included. Salivary melatonin and cortisol were measured over a 24h-period. Sleep-wake patterns were characterized by two weeks of actigraphy recordings and sleep diaries. Sleepiness, fatigue, sleep quality, and general health were assessed by questionnaires.

Description:

The hypothalamus is a part of the brain containing a number of nuclei with a variety of functions. It is central in the regulation of hormone secretion, sleep, and circadian functions. The suprachiasmatic nucleus of the hypothalamus is a key component in controlling circadian rhythms and generates the rhythm of melatonin secretion from the pineal gland and cortisol secretion. Both melatonin and cortisol are involved in the regulation of circadian rhythms and sleep.

Craniopharyngiomas are a type of brain tumors that usually affect the hypothalamus indirectly. In general, they are locally aggressive invading crucial structures e.g. the hypothalamus, the pituitary, and the optic nerve. Compared to healthy controls, craniopharyngioma patients have previously been reported with impaired quality of life, increased self-reported general and physical fatigue, increased daytime sleepiness, and increased prevalence of severe sleepiness

Damage to the hypothalamus by local tumour or its treatment might involve the suprachiasmatic nucleus and thereby melatonin secretion leading to disturbed circadian function causing clinical manifestations in terms of daytime sleepiness and fatigue.

The investigators aimed to assess the influence of craniopharyngiomas or their treatment on melatonin secretion, and the association with sleep pattern, sleep quality, fatigue, and sleepiness.

15 patients with craniopharyngioma and 15 gender, age, and BMI matched healthy controls were included. Salivary melatonin and cortisol were measured over a 24h-period. Sleep-wake patterns were characterized by two weeks of actigraphy recordings and sleep diaries. Sleepiness, fatigue, sleep quality, and general health were assessed by questionnaires.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2016
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients treated for former craniopharyngiomas

• aged 18-70 years.

Exclusion Criteria:

• insufficient substitution of pituitary hormone deficiencies within six months prior to inclusion

• total blindness

• clinically significant liver or renal disease

• use of non-steroid anti-inflammatory drugs

• beta-receptor antagonists

• antidepressants that affect serotonin

• active cancer

• epileptic seizures

• working night-shift

• breast feeding

• pregnancy,

• alcohol or drug abuse

Related Conditions & MeSH terms

• Craniopharyngioma
• Parasomnias
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Glostrup University Hospital, Copenhagen

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	sleep-wake characteristics	Sleep-wake pattern of individual participants measured by diaries	1 year
Primary	24h melatonin and cortisol concentrations		1 year
Secondary	actigraphy	Measuring daily activity by actigraph measurements	1 year