Sleep Wake and Melatonin Pattern in Craniopharyngioma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Glostrup University Hospital, Copenhagen
Information provided by (Responsible Party):
Ulla Feldt-Rasmussen, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01881854
First received: June 12, 2013
Last updated: June 17, 2013
Last verified: June 2013
  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 Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 24h melatonin and cortisol concentrations [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • actigraphy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measuring daily activity by actigraph measurements


Other Outcome Measures:
  • sleep-wake characteristics [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Sleep-wake pattern of individual participants measured by diaries


Enrollment: 30
Study Start Date: November 2011
Estimated Study Completion Date: September 2013
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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01881854

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

No publications provided

Responsible Party: Ulla Feldt-Rasmussen, Professor, chief physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01881854     History of Changes
Other Study ID Numbers: Cranio-sleep-melatonin
Study First Received: June 12, 2013
Last Updated: June 17, 2013
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Ethics Committee

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Adamantinoma
Craniopharyngioma
Parasomnias
Sleep Disorders
Bone Diseases
Bone Neoplasms
Chronobiology Disorders
Dyssomnias
Mental Disorders
Musculoskeletal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Nervous System Diseases
Neuroectodermal Tumors
Neurologic Manifestations
Occupational Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 23, 2014