Sleep Wake and Melatonin Pattern in Craniopharyngioma

NCT01881854 | Completed

• 1 other identifier: Cranio-sleep-melatonin
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Sleep Disorders, Circadian Rhythm; Craniopharyngioma

Outcome Measures

Primary Outcomes (1)

• 24h melatonin and cortisol concentrations

  1 year

Secondary Outcomes (1)

• actigraphy

  1 year

Other Outcomes (1)

• sleep-wake characteristics

  1 year

Study Arms (2)

craniopharyngioma

Patients treated for craniopharyngioma, most of them on pituitary substitution therapy

Healthy controls

matched for gender, age and BMI to the patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated for craniopharyngioma with surgery and some also irradiation

You may qualify if:

• patients treated for former craniopharyngiomas
• aged 18-70 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Glostrup University Hospital, Copenhagen: collaborator

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Craniopharyngioma

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue

Study Officials

• Ulla Feldt-Rasmussen, Professor

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, chief physician

Study Record Dates

• First Submitted: June 12, 2013
• First Posted: June 20, 2013
• Study Start: November 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02