The aim of this study is to examine arousals in PTSD, and to investigate the correlation of arousals with nocturnal excretion of hormones of the HPA-axis.
ID
Source
Brief title
Condition
- Sleep disturbances (incl subtypes)
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are the number of arousals and nocturnal exctrion
of cortisol.
Secondary outcome
Secondary objectives are
1. Other PSG parameters
2. Nocturnal excretion of catecholamines and hormones of the HPA axis (other
than cortisol)
3. Correlations of plasma concentration of catecholamines and hormones of
the HPA axis with number of arousals and other PSG parameters
4. Correlation of subjective sleep complaints with number of
awakenings and other PSG parameters
5. Correlation of objective and subjective sleep quality with temperament,
general
psychological and somatic well being, according to VTCI, SCL-90 and CIS
6. Correlation of performance on memory task (delayed recall) and number of
arousals
Background summary
Posttraumatic stress disorder (PTSD) is an often chronic and disabling
disorder. Sleep complaints are reported in 70 % of the PTSD patients and may be
caused by altered and hypothalamo- pituitary- adrenal (HPA) axis activity in
PTSD.
Study objective
The aim of this study is to examine arousals in PTSD, and to investigate the
correlation of arousals with nocturnal excretion of hormones of the HPA-axis.
Study design
After screening for sleep disorders, aneamia and other relevant medical
conditions, the subjects will sleep for two nights at the sleep unit of the
Military Mental Health Care (MGGZ). During the second night polysomnographic
recordings will be obtained, and multiple blood samples will be obtained
through an intravenous catheter. In addition, subjective sleep quality will be
measured with a self-administered sleep questionnaire (Pittsburgh Sleep Quality
Index), and a sleep calendar. Psychological en physical well being will be
assessed with CIS, and SCL-90. Temperament will be assessed with the VTCI. On
the second night a memory task (15 words test) and a sustained attention test
(Bourdon Wiersma Test) will be performed. Furthermore, a short form of the WAIS
III will be performed to assess IQ. In the morning delayed recall of the 15
words will be assessed.
Study burden and risks
1. Three nights PSG in sleep laboratory
The sleep registrations at Kempenhaeghe will be done at friday nights, when the
ward is available for subjects of this study only.
The sleep lab of the MGGZ is in a quiet part of the MGGZ where no patients are
admitted.
2. Intravenous cannulation
There is a very small risk of infection and bleeding associated with
intravenous cannulation, which is prevented by proper techniques and skilled
personnel.
3. Blood sampling. A maximum amount of 250 ml will be drawn over a time period
of 12 hours. Patients with anaemia will not be allowed in this protocol.
4. Psychological testing can lead to a temporary increase of symptoms. This
will be explained to all participants beforehand. Participants can contact the
investigators and the clinic of the MGGZ when complaints will not diminish.
heidelberglaan 100
3584 CX Utrecht
Nederland
heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
- Age between 18 - 55
- Male
- Veterans or active military personnel
- History of deployment (PTSD and trauma controls)
- CAPS > 50 (PTSD patients)
Exclusion criteria
- Substance or alcohol dependence within the past six months
- History of psychiatric disorders (trauma controls, healthy controls)
- CAPS > 18 (trauma controls)
- Significant psychological trauma in the past (healthy controls)
- Any clinically significant abnormal finding during medical history or physical examination
- Anemia (hemoglobin < 8.5 mmol/l)
- Sleep disturbed breathing (SDB) or periodic limb movement disorder (PLMD)
- Use of any psychotropic medication.
- Chronic benzodiazepine use. Benzodiazepine use on demand will be stopped at least two weeks before the study nights. A subject can only participate if no rebound effects after cessation of benzodiazepines are reported.
Design
Recruitment
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 | NL18585.041.07 |