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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04751019
Other study ID # IRAS 262339
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2019
Est. completion date January 31, 2020

Study information

Verified date February 2021
Source Surrey and Borders Partnership NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The use of amber glasses will aid the patient to fall asleep without the need for the use of hypnotic medication.


Description:

Sleep disturbance and insomnia is extremely common and affects up to 30% of adults at any given time. Moreover, sleep disturbance is known to be particularly prevalent in patients suffering from mental illness including affective disorders, schizophrenia, anxiety (Baglioni, 2016). We hypothesise that the use of amber glasses will aid the time taken to fall asleep without the need for the use of hypnotic medication.A prospective study looking at 15 new patients admitted to one mental health ward will be undertaken. Data will be collected on twice weekly basis on the patient's use of: amber glasses alone, hypnotic medication alone or both. Hypnotic medication will include sedating antihistamines, benzodiazepines and non-benzodiazepine hypnotics such as zopiclone. Medication prescribed for dual purpose will be assumed to be used for the treatment of insomnia if given after 2300 hours. Each patient will be enrolled for a period of 4 weeks and the review of use and suitability will take place in ward review meetings. Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 31, 2020
Est. primary completion date January 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age over 18 years - Male or female gender - Presentation of mental illness (of psychotic nature, severe depression or anxiety) - Able to provide informed consent Exclusion Criteria: - Patient does not consent - High risk assessment of self-harm or harm to others

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Amber Glasses
It is hoped that the use of amber glasses to complement the natural sleep-wake by inducing a perceived 'physiological darkness' to aid the secretion of melatonin should help sleep and reduce the use of hypnotic medication

Locations

Country Name City State
United Kingdom Surrey and Borders NHS Foundation Trust Leatherhead Surrey

Sponsors (1)

Lead Sponsor Collaborator
Surrey and Borders Partnership NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The difference in the use of hypnotic medication as compared with existing data from a similar population. Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment (PSQI) tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period. These historic admissions will be matched for diagnosis. 4 weeks
Secondary Change in sleep quality as measured by a point score change in the PSQI. 4 weeks
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