Pilot study on the effects of transcranial magnetic stimulation on sleep parameters in patients with insomnia

Pilot study on the effects of transcranial magnetic stimulation on sleep parameters in patients with insomnia - TMS-Insomnie

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00039744

Enrollment

Registered

2026-03-26

Start date

2025-07-08

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

F51.0

Interventions

Group 1: Ptients suffering from insomnia receive 2 cycles of neurophysiologically effective transcranial magnetic stimulation (TMS) of the right dorsolateral prefrontal cortex in “continuous theta bur

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - Body Mass Index (BMI) 1 month - Insomnia Severity Index (ISI) > 8

Exclusion criteria

Exclusion criteria: - Non-removable ferromagnetic materials near the stimulation site - Concerns of participants regarding TMS - Shift work during study days - Reported acute and exceptional stress situations - Serious neurological conditions (e.g., following neurosurgical procedures) - Severe psychiatric disorders (F00-F39, F53-F59, F70-79) - infections with fever up to 2 weeks prior to study start - Inadequately treated internal medical conditions (including active cancer diseases) - Cardiovascular risk status (excluding conditions stably controlled with medication) - Known nocturia (>1 time/night) or incontinence - Severe respiratory diseases, sleep-related breathing disorders, and other sleep disorders except insomnia - Cycle-related conditions, current pregnancy, or breastfeeding - =2 non-herbal sleep medications used in the past without improvement of symptoms - Use of medications that very frequently (>10%) to frequently (=1–<10%) cause sleep disturbances - Previous TMS treatment

Design outcomes

Primary

Measure	Time frame
Sleep structure and quality on the night following treatment, measured using a simplified, EEG-based sleep assessment under controlled conditions in a sleep laboratory	—

Secondary

Measure	Time frame
self-reported sleepiness and well-being, assessed immediately after stimulation in the evening and on the following morning using validated questionnaires	—

Countries

Germany

Contacts

Public ContactIngo Fietze

Charité-Universitätsmedizin Berlin, Interdisziplinäres Schlafmedizinisches Zentrum

ingo.fietze@charite.de+4930450513122

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026