Circadian Sleep-wake Cycles and Light Therapy in Borderli... | NCT01311193

Studies
Circadian Sleep-wake Cycles and Light Therapy in Borderline Personality Disorder

NCT01311193

Sponsor

University Hospital, Basel, Switzerland

Status

Completed

Last Update Posted

Mar 9, 2011Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Borderline Personality Disorder
Sleep Disturbances
Depression

Interventions

light therapy

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 3, 2011

First Submission Date that Met QC Criteria

Mar 7, 2011

First Posted Date

Mar 9, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2011

Last Update Posted Date

Mar 9, 2011Estimated

Name	Class
Velux Fonden	OTHER
Lumie UK	UNKNOWN

Description Module

Brief Summary

Individuals with borderline personality disorder (BPD) frequently suffer from emotional instability, daytime fatigue and sleep disturbances. The investigators examined circadian rhythms, sleep and well-being in women with BPD under their habitual life conditions with and without light treatment.

Treated women diagnosed with BPD were investigated during 3 weeks without and 3 weeks with morning LT. Rest-activity cycles were continuously measured using wrist actigraphy, together with proximal skin temperature. Saliva samples were collected weekly to determine the diurnal melatonin rhythm. A range of self-ratings and questionnaires were used to assess depression and clinical state throughout the 6-week protocol. Ten matched healthy women followed the same 6-week protocol without light treatment.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
light therapy	Experimental	Morning bright light treatment (at 8000 lux for 40min, daily during 3 weeks)	Other: light therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
light therapy	Other	early morning exposures to bright light, 8000lux for 40min, daily during 3 weeks	light therapy

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Borderline Personality Disorder (DSM IV-criteria)
German-speaking
normal ocular function

Exclusion Criteria:

lack of compliance

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Cajochen, PhD	Centre for Chronobiology, Psychiatric Hospital, University of Basel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Chronobiology, Psychiatric Hospital, University of Basel		Basel	Canton of Basel-City	4012	Switzerland

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D001883	Borderline Personality Disorder
D020447	Parasomnias
D003863	Depression

Ancestor Terms

ID	Term
D010554	Personality Disorders
D001523	Mental Disorders
D012893	Sleep Wake Disorders
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided