Background:

It has been estimated that between 25% and 40% of people living with dementia suffer from sleep disturbances, and there are currently no known effective treatments. Sleep disturbances may be the direct result of dementia or due to other comorbidities, such as pain and limited mobility. If carers’ sleep is also disturbed, carers too can become tired and stressed, and this sometimes results in the breakdown of care in the home.

Objectives:

To design an evidence-based manualised non-pharmacological therapy for sleep disturbances and test it for feasibility and acceptability.

Design:

A single-blind, randomised, parallel-group feasibility trial, with participants randomised 2 : 1 to intervention or treatment as usual (TAU).

Setting:

Five memory services in two London NHS trusts and Join Dementia Research (JDR).

Participants:

The study recruited people with dementia and sleep disturbances (who scored ≥ 4 on at least one question on the Sleep Disorders Inventory) and their primary family carers.

Intervention:

All participants were given an Actiwatch (CamNtech Ltd, Cambridge, UK) to wear to record their sleep patterns for 2 weeks before randomisation. The intervention group received Dementia RElAted Manual for Sleep; STrAtegies for RelaTives (DREAMS START). This was designed as a six-session, manual-based intervention for carers of people with dementia, delivered by trained and clinically supervised psychology graduates, based on evidence about managing sleep disturbance in people with dementia. It uses the structure of a previous manual-based treatment, STrAtegies for RelaTives (START). Family carers were consulted about structure, content and design. Sessions were interactive, and each involved techniques, tasks to practise between sessions, relaxation and a recapitulation on the previous session. The sessions covered understanding sleep and dementia, making a plan (incorporating information from Actiwatch read-outs and a light box to increase light), daytime activity and routine, difficult night-time behaviours, taking care of your own (carer’s) sleep and using the strategies in the future. Carers kept their own manual, light box and relaxation recordings post intervention.

Randomisation and blinding:

A statistician created an electronic randomisation list, stratified by site, using random permuted blocks. Those assessing the outcome were blinded to allocation; participants were not blinded.

Main outcome measures:

Outcomes were assessed at 3 months. (1) Feasibility, defined as the percentage of eligible people who consented to the study recruitment, with an expected value of 50% [95% confidence interval (CI) 41% to 59%]. (2) Acceptability, defined as the percentage of intervention group participants attending ≥ 4 intervention sessions, with an expected value of 75% (95% CI 59% to 87%). The predetermined criterion for progression to the main trial was acceptability of ≥ 70%.

Results:

Of 95 eligible patients referred, 63 (66%, 95% CI 56% to 76%) consented between 4 August 2016 and 24 March 2017: 61 from memory clinics and two from JDR. Of these, 62 participants (65%, 95% CI 55% to 75%) were randomised: 42 to the intervention arm and 20 to the TAU arm. Thirty-seven out of 42 participants (88%, 95% CI 75% to 96%) adhered to the intervention.

Conclusions:

The results show that the randomised controlled trial is feasible and that the intervention is acceptable. A higher than expected proportion of eligible patients referred consented to the study and adhered to the intervention.

Limitations:

Participants were not blinded and were recruited only in London.

Future work:

The results of this trial indicate that a future efficacy trial is warranted.

Trial registration:

Current Controlled Trials ISCTRN36983298.

Funding:

This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 71. See the NIHR Journals Library website for further project information. Funding was also provided by Camden and Islington NHS Foundation Trust and Barnet, Enfield and Haringey Mental Health NHS Trust to pay for excess treatment costs from therapist training and supervision and intervention delivery.

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 14/220/06. The contractual start date was in February 2016. The draft report began editorial review in November 2017 and was accepted for publication in June 2018. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Gill Livingston is on the National Institute for Health Research (NIHR) postdoctoral fellowship board. Gill Livingston and Penny Rapaport have grants from NIHR/Economic and Social Research Council, NIHR Health Technology Assessment (HTA) programme and the Alzheimer’s Society and are supported by North Thames NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC). Simon D Kyle reports grant funding from NIHR HTA, NIHR Oxford Biomedical Research Centre, Arthritis Research UK and the Dr Mortimer & Theresa Sackler Foundation. Claudia Cooper and Gill Livingston are supported by the University College London NIHR Biomedical Research Unit. James A Pickett is an employee of the Alzheimer’s Society. Colin A Espie reports grants from the NIHR HTA programme, NIHR Oxford Biomedical Research Centre, the Wellcome Trust, Education Endowment Foundation and the Dr Mortimer & Theresa Sackler Foundation. In addition, he has a patent US Patent Application Serial No. 14/172,347 INTERACTIVE SYSTEM FOR SLEEP IMPROVEMENT: Docket No. HAME-001 issued and is co-founder and Chief Medical Officer of Big Health Ltd (London, UK), which has developed Sleepio, an online digital cognitive–behavioural therapy intervention for insomnia. He is also a shareholder in Big Health Ltd.