Sleep Wake and Melatonin Pattern in Craniopharyngioma

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT01881854
Collaborator
Glostrup University Hospital, Copenhagen (Other)
30
58

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Cross Sectional Study of Sleep-wake and Melatonin Patterns in Patients Treated for Craniopharyngiomas Compared to Matched Controls
    Study Start Date :
    Nov 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Sep 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    craniopharyngioma

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

    Healthy controls

    matched for gender, age and BMI to the patients

    Outcome Measures

    Primary Outcome Measures

    1. 24h melatonin and cortisol concentrations [1 year]

    Secondary Outcome Measures

    1. actigraphy [1 year]

      Measuring daily activity by actigraph measurements

    Other Outcome Measures

    1. sleep-wake characteristics [1 year]

      Sleep-wake pattern of individual participants measured by diaries

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Rigshospitalet, Denmark
    • Glostrup University Hospital, Copenhagen

    Investigators

    • Principal Investigator: Ulla Feldt-Rasmussen, Professor, Rigshospitalet, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ulla Feldt-Rasmussen, Professor, chief physician, Rigshospitalet, Denmark
    ClinicalTrials.gov Identifier:
    NCT01881854
    Other Study ID Numbers:
    • Cranio-sleep-melatonin
    First Posted:
    Jun 20, 2013
    Last Update Posted:
    Feb 23, 2017
    Last Verified:
    Feb 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 23, 2017