The Use of Amber Glasses in Improving Sleep

NCT ID: NCT04751019

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-11
• Study Completion Date: 2020-01-31

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.

Conditions

Sleep Disturbance; Insomnia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Surrey and Borders Partnership NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Surrey and Borders NHS Foundation Trust

Leatherhead, Surrey, United Kingdom

Countries

United Kingdom

Other Identifiers

IRAS 262339

Identifier Type: -

Identifier Source: org_study_id