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Completed

NCT Number: NCT01881854

Sleep Wake and Melatonin Pattern in Craniopharyngioma

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 24h melatonin and cortisol concentrations

    Time frame: 1 year

Secondary outcomes

  1. actigraphy

    Time frame: 1 year

    Measuring daily activity by actigraph measurements

Other outcomes

  1. sleep-wake characteristics

    Time frame: 1 year

    Sleep-wake pattern of individual participants measured by diaries

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Glostrup University Hospital, Copenhagen

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2016
First posted
Jun 20, 2013
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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