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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Sleep Disorders, Circadian Rhythm, Craniopharyngioma

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

24h melatonin and cortisol concentrations

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Ulla Feldt-Rasmussen, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rigshospitalet, Denmark

Authority:

Denmark: Danish Dataprotection Agency

Study ID:

Cranio-sleep-melatonin

NCT ID:

NCT01881854

Start Date:

November 2011

Completion Date:

September 2013

Related Keywords:

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

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