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The Use of Amber Glasses in Improving Sleep

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ClinicalTrials.gov Identifier: NCT04751019
Recruitment Status : Completed
First Posted : February 11, 2021
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Surrey and Borders Partnership NHS Foundation Trust

Study Description
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Brief Summary:
The use of amber glasses will aid the patient to fall asleep without the need for the use of hypnotic medication.

Condition or disease Intervention/treatment Phase
Sleep Disturbance Insomnia Device: Amber Glasses Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Amber Glasses in Improving Sleep and Reducing the Use of Hypnotic Medication in an Inpatient Mental Health Setting: Pilot Study
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : January 31, 2020
Actual Study Completion Date : January 31, 2020
Arms and Interventions
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Intervention Details:
  • 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

Outcome Measures
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Primary Outcome Measures :
  1. The difference in the use of hypnotic medication as compared with existing data from a similar population. [ Time Frame: 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 :
  1. Change in sleep quality as measured by a point score change in the PSQI. [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04751019


Locations
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United Kingdom
Surrey and Borders NHS Foundation Trust
Leatherhead, Surrey, United Kingdom, KT22 7AD
Sponsors and Collaborators
Surrey and Borders Partnership NHS Foundation Trust
More Information
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Responsible Party: Surrey and Borders Partnership NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04751019    
Other Study ID Numbers: IRAS 262339
First Posted: February 11, 2021    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dyssomnias
Parasomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders