Sleep Wake and Melatonin Pattern in Craniopharyngioma

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.

Study Overview

• Status: Completed
• Conditions: Craniopharyngioma; Sleep Disorders, Circadian Rhythm

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients treated for craniopharyngioma with surgery and some also irradiation

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
craniopharyngioma; Patients treated for craniopharyngioma, most of them on pituitary substitution therapy
Healthy controls; matched for gender, age and BMI to the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
24h melatonin and cortisol concentrations	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
actigraphy	Measuring daily activity by actigraph measurements	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep-wake characteristics	Sleep-wake pattern of individual participants measured by diaries	1 year

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Collaborators: Glostrup University Hospital, Copenhagen

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): September 1, 2012
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: June 12, 2013
• First Submitted That Met QC Criteria: June 17, 2013
• First Posted (ESTIMATE): June 20, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2017
• Last Update Submitted That Met QC Criteria: February 21, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Dyssomnias; Neoplasms by Site; Neurologic Manifestations; Musculoskeletal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Occupational Diseases; Bone Diseases; Bone Neoplasms; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm; Craniopharyngioma; Adamantinoma
• Other Study ID Numbers: Cranio-sleep-melatonin

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED