Research question:1. Do patients exhibit disturbances of sleep duration or circadian locomotor rhythmicity before surgery? 2. Do these variables change after surgery?
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Registration of day-night rhythmicity using actigraphy and sleep diaries
2. Questionnaires assessing sleep quality and quality of life
3. Clinical parameters from standard patient care, e.g. laboratory results, MRI
of pituitary region, and visual field assessment
4. Melatonin in saliva
5. Visual Evoked Potentials
Secondary outcome
none
Background summary
Patients treated for a nonfunctioning pituitary macroadenoma suffer from
subjective and objective disturbances of sleep quality and sleep-wake
rhythmicity. These disturbances might be attributed to dysfunction of the
central biological clock, a structure in the hypothalamus that lays adjacent to
the tumor.
It is unknown whether these invalidating and irreversible symptoms are caused
by compression of the tumor against the biological clock (in that case,
symptoms would be present before the surgery), or by surgical manipulation
during the transsphenoidal removal of the adenoma. Knowledge on the moment when
complaints arise will aid in formulating strategies to prevent these
complaints.
Study objective
Research question:
1. Do patients exhibit disturbances of sleep duration or circadian locomotor
rhythmicity before surgery?
2. Do these variables change after surgery?
Study design
In 50 patients with a NFMA, we will measure sleep quality and sleep-wake
rhythmicity both before and after surgery.
Study burden and risks
Low burden, no risks.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Diagnosed nonfunctioning pituitary macroadenoma, not yet received surgery
Exclusion criteria
age <18 years or > 70 years old
mentally incompentent
Design
Recruitment
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 | NL53585.058.15 |