The Use of Amber Glasses in Improving Sleep

Not Applicable

Completed

• Conditions: Insomnia; Sleep Disturbance

• Registration Number: NCT04751019
• Lead Sponsor: Surrey and Borders Partnership NHS Foundation Trust

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2019-03-11
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-02
• Study First Submitted: 2021-02-05
• Study First Submitted QC: 2021-02-10
• Last Update Submitted: 2021-02-10
• Study First Posted: 2021-02-11
• Last Update Posted: 2021-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The difference in the use of hypnotic medication as compared with existing data from a similar population.	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change in sleep quality as measured by a point score change in the PSQI.	4 weeks

Trial Locations

Locations (1)

Surrey and Borders NHS Foundation Trust; 🇬🇧 Leatherhead, Surrey, United Kingdom