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Sleep Wake and Melatonin Pattern in Craniopharyngioma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01881854
First Posted: June 20, 2013
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Glostrup University Hospital, Copenhagen
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark
  Purpose

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
Sleep Disorders, Circadian Rhythm Craniopharyngioma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ulla Feldt-Rasmussen, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 24h melatonin and cortisol concentrations [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • actigraphy [ Time Frame: 1 year ]
    Measuring daily activity by actigraph measurements


Other Outcome Measures:
  • sleep-wake characteristics [ Time Frame: 1 year ]
    Sleep-wake pattern of individual participants measured by diaries


Enrollment: 30
Study Start Date: November 2011
Study Completion Date: September 2016
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
craniopharyngioma
Patients treated for craniopharyngioma, most of them on pituitary substitution therapy
Healthy controls
matched for gender, age and BMI to the patients

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients treated for craniopharyngioma with surgery and some also irradiation
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01881854


Sponsors and Collaborators
Rigshospitalet, Denmark
Glostrup University Hospital, Copenhagen
Investigators
Principal Investigator: Ulla Feldt-Rasmussen, Professor Rigshospitalet, Denmark
  More Information

Responsible Party: Ulla Feldt-Rasmussen, Professor, chief physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01881854     History of Changes
Other Study ID Numbers: Cranio-sleep-melatonin
First Submitted: June 12, 2013
First Posted: June 20, 2013
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Sleep Wake Disorders
Parasomnias
Craniopharyngioma
Adamantinoma
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases
Chronobiology Disorders
Dyssomnias
Occupational Diseases
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants