1. Are there differences between patients and controls in circadian movement rhythmicity and sleep duration?2. Are these objective measures associated with subjective sleep complaints?3. Are these objective measures associated with decreased quality…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Registration of day-night rhythmicity and objective sleep duration using
actigraphy and sleep diaries
Secondary outcome
Quality of life and subjective sleep quality
Background summary
Patients treated for nonfunctioning pituitary adenoma (NFMA) suffer from
subjective and objective sleeping disorders, despite optimal substitution of
pituitary hormones. A possible explanation for these disorders could be that
the pituitary tumor itself, and/or the effects of the treatment
(surgery/radiotherapy), lead to hypothalamic damage and therefore to
hypothalamic dysfunction.
In a pilotstudy in the Leiden University Medical Center, a group of 17 patients
was studied for different functions as mediated by the hypothalamus (sleep,
biorhythm, blood pressure regulation, temperature, heart rate variability). The
day-night rhythm of activity was studied using actigraphy (Actiwatch). The
study concluded that there were signs of disruption of the circadian
rhythmicity. The current study aims to further confirm the disturbances in a
larger cohort of NFMA patients, and to study possible factors that influence
those disruptions.
Furthermore, in the pilotstudy we found indications of reduced activity early
in the morning, possibly related to the deficit of cortisol in cortisol
deficient patients. To study this hypothesis, the current study will perform
the measurements of actigraphy and heart rate variability also in patients with
primary adrenalinsufficiency or adrenalectomy. These patients will serve as a
model for hydrocortisondependency in the absence of a pituitary disorder.
Study objective
1. Are there differences between patients and controls in circadian movement
rhythmicity and sleep duration?
2. Are these objective measures associated with subjective sleep complaints?
3. Are these objective measures associated with decreased quality of life?
4. Which patients/ treatment characteristics influence the disruptions of
circadian rhythmicity?
Study design
Cross-sectional study in which patients with a non-functioning pituitary
adenoma, patients with primary adrenal insufficiency and healthy controls wear
an Actigraph (light-weight whatch) for one week, and fill in several
questionnaires
Study burden and risks
No risk, minimal burden.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Informed consent
Mentally competent
Age 18-70 years
NFMA patients: treated for non-functioning pituitary macroadenoma, adequate substitution of any hormone deficiencies for at least 4 months. Documented adenopituitary deficiencies.
Hypocortisol patients: treatment for primary adrenal gland insufficiency or bilateral adrenalectomy, adequate substitution of cortisol for at least 4 months.
Exclusion criteria
Pregnancy
Diagnosted sleeping disorder
Diseases of the hypothalamus or pituitary gland other that NFMA
Chronic use of sleep medication or sedative medication
Age >70 years
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL42333.058.12 |