SLEEP DEEP: sleep deepening as treatment augmentation for post-traumatic stress disorder

SLEEP DEEP: sleep deepening as treatment augmentation for post-traumatic stress disorder - SLEEP DEEP

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON53336

Enrollment

120

Registered

2023-08-11

Start date

2025-05-08

Completion date

Unknown

Last updated

2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post-traumatic stress disorder PTSD post-traumatic stress disorder, PTSD

Interventions

During each night of a 5-day treatment program for PTSD, we will use ambulatory, EEG-guided, closed-loop stimulation to administer subtle, non-arousing sounds, phase-locked to the up-phase of slow w

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - PTSD diagnosis according to DSM-5 criteria as assessed with the Clinician-administered PTSD scale for DSM-5 (CAPS-5, previous month version) - Indication to receive 5-day treatment program for PTSD - 18-65 years of age

Exclusion criteria

Exclusion criteria: - Current episode of psychotic or bipolar disorder or alcohol or drug dependence - Use of benzodiazepines or other sleep medication during study period - Use of other psychotropic medication than benzodiazepines/sleep medication, except when on a stable dose for at least 6 weeks (after start or alteration of dosage) - Irregular sleep/wake rhythm (outside PTSD itself) (imposed by e.g. regular nightshifts or cross timeline travel) - Severe hearing loss - Sleeping on stomach - Inability to understand or meet the study requirements, as assessed by the researchers

Design outcomes

Primary

Measure	Time frame
PTSD symptom level post-treatment (1 week and 3 months after end of treatment) is measured with the Clinician-administered PTSD scale for DSM-5 Revised (CAPS-5-R, previous week version) and the self-administrated PTSD checklist for DSM-5 (PCL-5).	—

Secondary

Measure	Time frame
Related to the secondary objective 1, the subjective ratings related to the traumatic memories under treatment measured with the index Trauma Memory Interview (ITMI) will be obtained at the beginning and end of each treatment day and the following day. During the interview heart rate will be measured using an ambulatory heart rate monitor. Also, at the beginning of each treatment day the PTSD symptom level (PCL-5) will be assessed. Related to the secondary objective 2, the objective sleep depth, sleep continuity measures, sleep architecture measures, and other physiological sleep measures will be obtained during each night of treatment. Also, sleep quality will be measured with a sleep diary.	—

Measure

Time frame

Related to the secondary objective 1, the subjective ratings related to the traumatic memories under treatment measured with the index Trauma Memory Interview (ITMI) will be obtained at the beginning and end of each treatment day and the following day. During the interview heart rate will be measured using an ambulatory heart rate monitor. Also, at the beginning of each treatment day the PTSD symptom level (PCL-5) will be assessed. Related to the secondary objective 2, the objective sleep depth, sleep continuity measures, sleep architecture measures, and other physiological sleep measures will be obtained during each night of treatment. Also, sleep quality will be measured with a sleep diary.

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Countries

Netherlands

Contacts

Public ContactHJF Marle

Amsterdam UMC

h.j.vanmarle@amsterdamumc.nl0625694914

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)