The aim of this study is to examine if an increased number of awakenings in PTSD is PTSD dependent or trauma dependent. Furthermore, the purpose of the study is to examine if the nocturnal excretion of cortisol is increased.
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 measure is number of awakenings of plasma cortisol
concentrations.
Secondary outcome
Secondary objectives are
1. Other PSG parameters
2. Nocturnal excretion of catecholamines and hormones of the HPA axis in
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
general
psychological and somatic well being, according to *Symptom
Checklist -
90* (SCL-90) and *Checklist Individuele Spankracht* (CIS).
6. Correlation of sleep endocrinology with temperament and personality,
as measured by *Temperament and Character Inventory*.
7. Awakening response curve of cortisol and ACTH in PTSD compared with
controls
Background summary
Posttraumatic stress disorder (PTSD) is an often chronic and disabling
disorder. Sleep complaints are reported in 70% of the PTSD patients.
Polysomnography (PSG) studies in PTSD have reported on an altered arousability
during the night. In these studies arousability has not yet been compared with
a trauma control group and non-trauma control group.
Sleep disturbances in PTSD may be correlated with altered noradrenergic
activity and hypothalamus- pituitary- adrenal axis (HPA) dysfunction.
Alterations in neuro-endocrine function after deployment have been found in
veterans without PTSD as well.
Study objective
The aim of this study is to examine if an increased number of awakenings in
PTSD is PTSD dependent or trauma dependent. Furthermore, the purpose of the
study is to examine if the nocturnal excretion of cortisol is increased.
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; Militaire Geestelijke Gezondheidszorg).
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.
Study burden and risks
Risks and burden for patients includes: admission sleep laboratorium,
intravenous cannulation, psychological testing
1. Admission
During the admission at the clinic, the contact with patients will be minimised
as the participants will stay at a separate part (research unit) of the clinic.
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, 250 ml drawn blood can give some dizziness in patients with
mild anaemia. Therefore, patients with anaemia will be excluded.
4. Psychological testing can lead to a temporary increase of symptomes. This
will be explainted to all participants. Participants can contact the
investigators and the clinic of the MGGZ in case of emergencies.
heidelberglaan 100
3584 CX Utrecht
Nederland
heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
male, age 18-65, CAPS > 50 (patients)
Exclusion criteria
substance /alcoholabuse within 6 months
psychotrophic medication
chronical benzodiazepin use
History of psychiatric disorder (controls), CAPS > 18 (contorls)
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 | NL16226.041.07 |