The Use of Amber Glasses in Improving Sleep

NCT04751019 | Completed

• 1 other identifier: IRAS 262339
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Disturbance; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in sleep quality as measured by a point score change in the PSQI.

  4 weeks

Interventions

Amber Glasses DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Male or female gender
• Presentation of mental illness (of psychotic nature, severe depression or anxiety)
• Able to provide informed consent

You may not qualify if:

• Patient does not consent
• High risk assessment of self-harm or harm to others

Sponsors & Collaborators

• Surrey and Borders Partnership NHS Foundation Trust: lead

Study Sites (1)

Surrey and Borders NHS Foundation Trust

Leatherhead, Surrey, KT22 7AD, United Kingdom

Location

MeSH Terms

Conditions

Parasomnias; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2021
• First Posted: February 11, 2021
• Study Start: March 11, 2019
• Primary Completion: January 31, 2020
• Study Completion: January 31, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)